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Supplement

Updated: April 9, 2021 6:05 PM

April 9, 2021 6:05 PM

“Company name: NS NY Distributor Inc
Brand name: NS NY Distributor Inc
Product recalled: Premium Orgazen 7000 and Ginseng Power 5000 capsules
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 09, 2021
Recall details: Company Announcement NS NY Distributor Inc is voluntarily recalling... See More all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA  analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in Premium OrgaZen 7000 and Ginseng Power 5000 makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

Consumers with underlying medical issues who take Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, NS NY Distributor Inc has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules. The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by amazon at www.amazon.com.

NS NY Distributor Inc is notifying customers who purchased through Amazon seller account Beauty.Kor by this press announcement. Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact NS NY Distributors Inc by email at NSNYdistributors@gmail.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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April 6, 2021 5:00 PM

“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cliffside Park, NJ, Yolo Studio is... See More voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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April 5, 2021 5:00 PM

“Company name: QMART
Brand name: IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 05, 2021
Recall details: Company Announcement Elmwood Park,... See More NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, QMART has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed via internet and fulfilled by amazon at www.amazon.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Check the full recall details on fda.gov
Source: FDA
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March 18, 2020 7:13 PM

“FDA announced the recall of Organic Kudzu Root Herbal Supplement by Mountain Rose Herbs due to the potential to be contaminated with Salmonella. No illnesses have been reported linked to this recall to date.

FDA advises consumers to discard the recalled products or return them to the... See More place of purchase. The product was distributed to customers in the US; and British Columbia, Nova Scotia, Ontario, and Quebec, in Canada.

- Organic Kudzu Root Herbal Supplement. All sizes. Lot # #24247-X / #24247.

Check the full recall on the FDA website fda.gov

Source: FDA
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Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

Recent Interesting Reports

July 14, 2021 7:27 PM

“I have had this bait and switch happened to me twice, once by this company and once by another company. The little wires are used by campers to cut small branches. Both times. I paid through PayPal. I ordered the rechargeable battery mini saw pruner. I received... See More a wire. Contacted the seller and the seller offered me a 50% refund, I told the seller I wanted 100% of my money back. The seller then replied that he would request a 60% refund but he could not give back 100% unless I returned the product to China. It costs like 30 dollars to send to China from the US even though they claim they are US based. The seller said they had shipped product and paid logistic cost to ship it to me and would I please accept the 60% and he hoped I understood. These bait and switch practices are illegal in the US. I escalated the case to Paypal. Then waited for the review. I then received an email from PayPal stating the seller had provided a shipping number and they found in favor of the seller. This message is generated by an auto responder. I then called PayPal and requested to speak to a PayPal agent. With in 2 minutes the person could see the Seller had done this over and over. They refunded my money and apologized for the inconvenience the Seller had caused me. It takes some time and effort, but persistence pays off. Also, it I s not your responsibility to return the product they shipped back to them at your expense.

They are located in Tennesee the key is to start the case through Paypal, when Paypal finds in favor of the seller. Call PayPal and speak with an agent. The message you received is sent out by an auto responder. PayPal agents can see that it us a recurring issue and your money will be refund. If you paid by credit card contact thr company snd ask them to do a charge back.
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July 11, 2021 10:50 AM

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July 6, 2021 2:14 PM

“On 5/11/21, ordered a wood cutter for final payment of 25.99.
I received some wire contraption instead. No answer to emails sent. Scam. Do not order any products from FaceBook unless you like throwing away your money. See Less
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July 12, 2021 2:22 PM

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July 14, 2021 2:37 PM

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July 19, 2021 9:02 PM

“Company name: Alpha Male Plus
Brand name: Alpha Male Plus
Product recalled: Alpha Male Plus Male Enhancer fruit chew
Reason of the recall: Undeclared Tadalafil
FDA Recall date: July 19, 2021
Recall details: Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha... See More Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Alpha Male Plus has not received any reports of adverse events related to this recall.

The tainted Alpha Male Plus Male Enhancer product was manufactured by Dr Manuel Mascarenas M.D. in Tucson, Arizona located at 5190 E Farness Dr Ste 104, 85712. Dr Mascarenas is the originator and manufacturer of these products for the global market. Alpha Male Plus was selected to act as the US distributor and distribute these products for the US market.

The tadalafil ingredient was never disclosed or made known to its US distributor and was only discovered through FDA laboratory analysis. Dr Manuel Mascarenas is solely responsible for the creation, formulation and proliferation of this product. Through the use of concealment, dishonest means and an unknowing 3rd party Dr Mascarenas was able to begin distributing this mislabeled and potentially harmful product to the US market.

Alpha Male Plus was marketed as a dietary supplement for male sexual enhancement and is packaged in 1strip per foil pouch within a cardboard box, UPC [8 60003 03770 6] [8 60003 74512 0].

The affected Alpha Male Plus Male Enhancer includes all lots. The product was distributed nationwide in the USA via internet directly to consumers via their website.

Company is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using or return to place of purchase/discard/contact their doctor, etc.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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July 13, 2021 8:00 PM

“Company name: Innoveix Pharmaceuticals, Inc.
Brand name: Innoveix Pharmaceuticals, Inc.
Product recalled: Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg
Reason of the recall: Potential lack of sterility assurance
FDA Recall date: July 13, 2021
Recall details: Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots... See More of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.

The affected products are injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. The products were distributed in glass vials contained in a small 3 inch by 3 inch white box.

Products were distributed nationwide to both customers and/or medical facilities. A full list of the affected products with the applicable lot numbers and expiration dates is as follows:

Product Lot/Expiry
Semorelin / Ipamorelin 3mg Lot# SIP210; Exp: 12/15/2021
Lot# SIP215; Exp: 01/14/2022
Lot# SIP220; Exp: 01/23/2022

AOD-9604 3mg Lot# AOD205; Exp: 11/09/2021
Lot# AOD210; Exp: 11/18/2021
Lot# AOD 215; Exp: 12/15/2021
Lot# AOD202; Exp: 11/09/2021

Check the full recall details on fda.gov

Source: FDA
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July 14, 2021 9:01 PM

“Company name: Johnson& Johnson
Brand name: Neutrogena, Aveeno
Product recalled: Sunscreen
Reason of the recall: Testing identified low levels of benzene
FDA Recall date: July 14, 2021
Recall details: Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen... See More product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below.

The only sunscreen products impacted are aerosol products, specifically: NEUTROGENA® Beach Defense® aerosol sunscreen:
- NEUTROGENA® Cool Dry Sport aerosol sunscreen
- NEUTROGENA® Invisible Daily™ defense aerosol sunscreen
- NEUTROGENA® Ultra Sheer® aerosol sunscreen
- AVEENO® Protect + Refresh aerosol sunscreen

Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure. Benzene is ubiquitous in the environment. Humans around the world have daily exposures indoors and outdoors from multiple sources. Benzene can be absorbed, to varying degrees, by inhalation, through the skin, and orally. Based on exposure modeling and the Environmental Protection Agency’s (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences. Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products.

While benzene is not an ingredient in any of our sunscreen products, it was detected in some samples of the impacted aerosol sunscreen finished products. We are investigating the cause of this issue, which is limited to certain aerosol sunscreen products. Sunscreen use is critical to public health. Melanoma incidences continue to increase worldwide, and the majority of cases are caused by excessive sun exposure. It is important that people everywhere continue to take appropriate sun protection measures, including the continued use of alternative sunscreen.

The recalled sunscreen products are packaged in aerosol cans. The products were distributed nationwide through a variety of retail channels.

Consumers should stop using these specific products and appropriately discard them.

Check the full recall details on fda.gov

Source: FDA
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July 7, 2021 11:46 AM

“Yesterday I bought and gave my dog two dream one twist dog treats. A couple hours later he was acting sick. Head down, not himself. He's a very energetic blue Lacy so this is unlike him. Yesterday evening I noticed he was trying to poo but couldn't.... See More He refused his normal treats (not the dream bone but he gets blue buffalo bits after potty breaks) this was another red flag . My boy never turns down a treat.
All last night he was restless. It's now 10 am on the day after giving him the dream bone twists. He's still restless, can't get comfy, lays down then stands up then sits down with his head down. Won't eat, even things he normally loves. I've rubbed his belly and tried to comfort him. I let him out and walked him around a bit to try and help his bowels move along. Still nothing. He ate a bit of grass which is normal when dogs don't feel good. A bit later he started puking a massive amount and I could see alot of undigested dream bone in it. Those dream bones are the only new thing hes had and now he's really sick. I'm scared after reading about other law suites and issues regarding this product that my dog might have obstructed bowels from eating eat. I'm watching him closely and ready to take him to the vet as soon as I see if he's going to improve after puking or not. Vet visits are really expensive and if he needs surgery or declines further I'm going to raise hell. It's not okay for money hungry corporates to line their pockets while falsely advertising its products as safe knowing dam well it's killing beloved animals. My dog deserved a treat not a fight for his life.
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Reported By SafelyHQ.com User

July 19, 2021 3:02 PM

“Company name: Pfizer
Brand name: CHANTIX
Product recalled: Smoking cessation treatment
Reason of the recall: N-Nitroso Varenicline content above ADI level
FDA Recall date: July 19, 2021
Recall details: Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and... See More eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options.

To date, Pfizer has not received any reports of adverse events that have been related to this recall.

The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021. 

For more recall details including the NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets check: fda.gov

Source: FDA
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