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United States

Updated: December 6, 2022 5:00 PM
Cranberry Sweets & More of Coos Bay, Oregon is voluntarily recalling its 4 and 8 ounce packages of "Mint Meltaways" candies because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.... See More The recalled Mint Meltaways were distributed to retail stores in Oregon and Washington and sold nationwide through mail orders since September 21, 2022 to date. No illnesses or deaths have been reported to date in connection with this problem.

The affected product is packaged in clear cellophane bags, net wt. 4oz and 8 oz. and has no UPC.  The front label is read “Mint Meltaways” and the back label is read “Heirloom Mint Meltaways”. The affected product is marked with lot #032123 on the bottom.

The recall was initiated after it was discovered that the Peanut Butter Meltaways product was mis-labeled as Heirloom Mint Meltaways and peanut was not declared on finished product label.  The firm’s subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging process.  The process has been corrected and the company has instituted additional safety checks and corrective actions.

This recall is being made with the knowledge of the U.S. Food and Drug Administration and the Oregon Department of Agriculture.

Consumers with a peanut allergy who have purchased the affected “Mint Meltaways” are urged not to consume the product and dispose of it or return it to their place of purchase for a full refund.

In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Cranberry Sweets & More
Brand name: Cranberry Sweets
Product recalled: Mint Meltaways
Reason of the recall: Potential or Undeclared Allergen/Peanut
FDA Recall date: December 06, 2022

Source: fda.gov
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Nestlé Purina PetCare Company is voluntarily recalling a limited amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food in 13.4 oz cans due to a labeling error. For a brief period on September 15, 2022, cans of... See More a different complete and balanced adult dog food, Purina ONE True Instinct Tender Cuts In Gravy With Real Turkey & Venison wet dog food, were labeled as PPVD EN Low Fat in one of our factories. The mislabeled diet is safe to feed, but it is not the intended formula for dogs requiring a prescription PPVD EN Low Fat diet, who may have sensitivities to traditional diets or difficulty digesting fat. While we have not received any reports to date of illness or injury to dogs fed this mislabeled product. The affected product was available by prescription only and distributed through veterinary clinics and other retailers with the ability to validate a prescription.

You can identify the mislabeled product by the UPC (38100 17599), production code (22581159 L4TR6) and “Best Before Sept 2024” date on the bottom of each PPVD EN Low Fat can.

We became aware of the issue after being contacted by several pet owners who observed the texture of food in their PPVD EN Low Fat cans was not the same as previous meals. The mislabeled product contains chunks in gravy, while the correct product looks more like a pate consistency.

We are conducting this voluntary recall as a precaution. We have asked our veterinary and other retail partners to remove the affected product. We also recommend that you discard any of the affected product you may have, and we will replace it as quickly as possible.

No other Purina products are impacted by this voluntary recall. We apologize to pet owners for any concerns or inconvenience this situation has caused. We’re pet owners too, and we know how important the health and well-being of our pets is, which is what led us to make this decision. We are taking action to investigate and notify pet owners and veterinarians of the situation. At Purina, pets always come first.

Company name: Nestle Purina PetCare Company
Product recalled: Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat (PPVD EN Low Fat) prescription wet dog food
Reason of the recall: Mislabeling / Labeling error
FDA Recall date: December 02, 2022

Source: fda.gov
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The Laundress New York issued a safety notice to stop using all their products due to the potential presence of elevated levels of bacteria in some of its products. These Bateria identified in product testing are so-called "opportunistic" pathogens, including Pseudomonas, which occur naturally in water and... See More soil. At the levels detected, these types of bacteria could present a risk of infection. To date, they are not aware of any adverse health impacts related to this issue.

You can see the list of the affected products here: thelaundresssafetynotice.com

The Laundress advises consumers to not use their products no matter if the product is or is not on the affected product list until their work with the US Consumer Product Safety Commission and Health Canada is complete. The investigation is ongoing.

People with a healthy immune system are usually not affected by these bacteria. People with weakened immune systems or external medical devices who are exposed to Pseudomonas face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: thelaundress.com
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Reply 6 days ago
Rocky Mountain Pies, LLC of Salt Lake City, Utah is recalling 31.88 oz French Silk Pie with inkjet code date 2 266, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to Tree Nuts (almonds) run the risk of serious or life-threatening... See More allergic reaction if they consume these products. Red Button Vintage Creamery French Silk Pie was distributed in Arizona, Utah, Oregon, Washington, Montana, Nevada, Colorado, Wyoming, and Idaho in retail stores. No illnesses have been reported to date.

Products are packaged in a clear plastic dome and black plastic base with a “Red Button Vintage Creamery” cardboard sleeve. Recall includes only products with the inkjet code on the dome that begins with “2 266”.  Only UPC code 0 41172 81290 9 is involved in this recall.

It was discovered at a retail location by staff that cases labeled “Turtle Cream Pies” contained Turtle Cream Pies, but were labeled with the “French Silk Pie” sleeves, resulting in the undeclared allergen, as the Turtle Cream Pie contains almonds and the French Silk Pie Sleeve does not declare almonds. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's pre-operational changeover packaging process. Consumers who have purchased Red Button Vintage Creamery French Silk Pie with the Lot Code beginning with “2 266” are urged to return it to the place of purchase for a full refund.

In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Rocky Mountain Pies, LLC
Brand name: Red Button Vintage Creamery
Product recalled: French Silk Pie
Reason of the recall: Undeclared almond
FDA Recall date: November 29, 2022

Source: fda.gov
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Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level.... See More All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022. Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022. There have been no reports of sterility failures to date with any of the sixty-three (63) lots.

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no complaints of vial breakage or injuries related to the additional fourteen (14) lots.

Exela did not recall the additional fourteen (14) lots previously because they did not appear to be impacted. During the latest inspection of Exela’s retain product from the fourteen (14) lots, one (1) vial showed breakage. There have been no field reports of personal injury to date across all the sixty-three (63) lots since the recall process started. However, out of an abundance of caution, Exela is adding the 14 lots to the on-going recall. The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2). The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

- Brand : Exela . Lot : P0001178 . Expire Date: 05/2023.
- Brand : Exela . Lot : P0001298 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001301 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001313 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001314 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001317 . Expire Date: 08/2023.
- Brand : Exela . Lot : P0001330 . Expire Date: 09/2023.
- Brand : Exela . Lot : P0001370 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001371 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001372 . Expire Date: 10/2023.
- Brand : Exela . Lot : P0001433 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001434 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001442 . Expire Date: 11/2023.
- Brand : Exela . Lot : P0001443 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001464 . Expire Date: 09/2023.
- Brand : Exela . Lot : P0001467 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001468 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001469 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001470 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001472 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001486 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001495 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001505 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001506 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001509 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001510 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001511 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001512 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001532 . Expire Date: 12/2023.
- Brand : Exela . Lot : P0001560 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001561 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001562 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001564 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001566 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001567 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001568 . Expire Date: 01/2024.
- Brand : Exela . Lot : P0001571 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001572 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001573 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001574 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001578 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001579 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001580 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001583 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001586 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001587 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001588 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001593 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001594 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001610 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001618 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001619 . Expire Date: 02/2024.
- Brand : Exela . Lot : P0001644 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001645 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001646 . Expire Date: 03/2024.
- Brand : Exela . Lot : P0001654 . Expire Date: 02/2024.
- Brand : Civica . Lot : P0001490 . Expire Date: 12/2023.
- Brand : Civica . Lot : P0001497 . Expire Date: 12/2023.
- Brand : Civica . Lot : P0001600 . Expire Date: 02/2024.
- Brand : Civica . Lot : P0001663 . Expire Date: 03/2024.

The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return).

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Exela Pharma Sciences, LLC
Brand name: Exela
Product recalled: Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial
Reason of the recall: Vial Breakage
FDA Recall date: November 29, 2022

Source: fda.gov
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The Arizona Department of Health Services (ADHS) announced the recall of specific marijuana products cultivated by PP Wellness due to possible contamination with Aspergillus, a fungus that can cause allergic reactions or infection, usually in people already sick with something else. These products were sold at multiple... See More locations with the product names listed below. To date, no illnesses have been reported.

The recalled products are:
Cultivator / Product Name / Batch Number / Product Type / Implicated Contaminant
- PP Wellness / El Alquimista / GH401 / Plant, Trim / Aspergillus
- PP Wellness / Tangie Head /GH403 / Plant, Trim / Aspergillus
- PP Wellness / Nasty Girl /GH404 / Plant, Trim / Aspergillus
- PP Wellness / The Juice / GH408/ Plant, Trim / Aspergillus
- PP Wellness / Gorilla Grapevine / GH413/ Plant, Trim / Aspergillus
- PP Wellness / The Juice / GH416 / Plant, Trim / Aspergillus

This announcement is being made out of an abundance of caution. Patients who have purchased potentially contaminated products should not ingest, inhale, or otherwise consume them and should dispose of them. Once ADHS discovered the positive test results, the establishment involved took immediate action to work with all distribution and retail partners to remove any potentially impacted products.

Aspergillus can cause allergic reactions or infections, usually in people already sick with something else. Symptoms range from asthma or cold-like symptoms to fever and chest pain among many others.

In case you experience harm from products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: azdhs.gov
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Mason Vitamins Inc. has issued a nationwide voluntary recall of the specific lot of Healthy Sense Daily Multiple with Iron and People’s Choice Women's Daily Vitamins with Iron due to Vitamin A, Vitamin B12, Vitamin C, Vitamin E and Pantothenic Acid amounts being lower than the declared... See More amount on the label which was determined during an FDA inspection. The products were sold nationwide at Bargain Barn, 99 Cents Only, Fruth Pharmacy, Joe V’s Smart Shop, Rose’s Discount Stores, Rex Discount Pharmacy, Star Discount Pharmacy, Propst Discount Pharmacy, Dollar Tree and limited distributors. To date, no illnesses related to these products have been reported.

Product Name: Healthy Sense Daily Multiple with Iron, Size: 20 tablets, UPC Code: 311845353238, Lot/Expiration Date: 25807G / 09/2024
Product Name: People’s Choice Women’s Daily Vitamins with Iron, Size: 30 tablets, UPC Code: 311845486882, Lot/Expiration Date: 25807G / 09/2024; A25807G / 09/2024; B25807G / 09/2024;C25807G / 09/2024; D25807G / 09/2024

No other People’s Choice and Healthy Sense products are affected by this recall. If customers have product affected by this voluntary recall, they should discard it immediately.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Mason Vitamins Inc.
Brand name: Healthy Sense and People’s Choice
Product recalled: Daily multi vitamin with Iron and Women’s daily vitamin with iron
Reason of the recall: Due to Vitamin 1, B12, C, E and Pantothenic Acid being lower than declared
FDA Recall date: November 17, 2022

Source: fda.gov
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Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin... See More Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. These actions are taken voluntarily with the knowledge of the FDA. Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port.

The excess heat may cause minor burns if those areas of the Controller are touched or could lead to fire. No serious injuries have been reported to Insulet as a result of this issue.

Omnipod 5 users are being notified by email with instructions on how to detect and reduce the risk of an issue with the charging port or cable.

In case you experienced issues with this product, it is important to report it.

Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod
Product recalled: Automated Insulin Delivery System
Reason of the recall: Issue with the Omnipod 5 Controller charging port and cable
FDA Recall date: November 15, 2022

Source: fda.gov
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Thornton, Colorado, Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. The hand sanitizer was distributed nationwide... See More in the USA to internet customers between June 2020 and March 2022. To date, Adam’s Polishes has not received any reports of injury, illness, or other adverse events related to this recall.

Risk Statement: Persons who accidently ingest (drink) these products are at risk for methanol poisoning. Substantial methanol ingestion can result in coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. This product is used as a hand sanitizer marketed to help decrease bacteria on the skin when soap and water are not available.

Adam’s Polishes Hand Sanitizer is packaged in 4oz., 8oz. 16oz., and one gallon bottles. These bottles are spray bottles for the 4oz, 8oz and 16oz and jugs for the gallon bottles. Lot numbers: 133470, 133471, 133472, 133473, 133474, 133475, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327

Consumers who have any recalled Adam’s Polishes Hand Sanitizer products should immediately stop using the product and dispose of it in accordance with local regulations.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Adam’s Polishes, LLC
Brand name: Adam’s Polishes
Product recalled: Hand sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: November 07, 2022

Source: fda.gov
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Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Insulet received reports from Omnipod... See More DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.

The Company’s investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death. There have been 50 complaints about this issue. No serious injuries or deaths have been reported as a result of this potential issue. As previously communicated to Omnipod DASH users, Insulet has identified an update to the Omnipod DASH PDM that will resolve this issue.

The Company expects to begin shipping updated Omnipod DASH PDMs to all current Omnipod DASH customers in the coming months. All affected Omnipod DASH consumers are being notified by email and local mail. Insulet has been providing customers with instructions to help reduce the risk of PDM battery issues.

This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod DASH
Product recalled: Personal Diabetes Managers
Reason of the recall: Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
FDA Recall date: November 05, 2022

Source: fda.gov
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