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Recall

Updated: February 23, 2024 8:01 PM
Backstage Center is issuing a recall of approximately 280 Bottles of Alipotec Raiz de Tejocote, dietary supplements, that are labeled with the "Alipotec King" sticker. This recall is being initiated because FDA analysis found that the product contains toxic yellow oleander. The product has been exclusively distributed... See More on Amazon.com since September 15, 2023. There have been no reports of injury or illness, to date.

The recalled product, which contains yellow oleander instead of tejocote, may induce serious neurologic, gastrointestinal, and cardiovascular adverse health effects. Symptoms may be severe or fatal, including nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac dysrhythmia, and others. Immediate medical attention is advised for consumers experiencing such symptoms.

Product Name: Alipotec King, Alipotec Raiz de TejocoteContainer
Description: Cylindrical bottle with a green top, white body, and contains approximately 30 granules, weighing a total of 0.35oz.
Lot Codes: 238124
Expiration date: 08-2027
Total Distributed: 280 Bottles
Consumer Instructions: Consumers should immediately discontinue use of the product.

In case you experience harm from extraneous materials, 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: Backstage Center
Brand name: Alipotec King
Product recalled: Alipotec Raiz de Tejocote
Reason of the recall: Product contains yellow oleander, a poisonous plant
FDA Recall date: February 23, 2024

Source: fda.gov
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San Luis, AZ, G.A. Mart dba H&Natural, is voluntarily recalling 2 lots of H&NATURAL TejoRoot, 10g pills, and 2 lots of H&NATURAL Brazil Seed, .167g Seeds to the consumer level. The products have been found via random FDA testing to contain yellow oleander, a poisonous plant native... See More to Mexico and Central America. H&NATURAL TejoRoot and H&NATURAL Brazil Seed were distributed Nationwide to via internet on their site, Amazon.com, and Walmart.com. The company has received one report of gastrointestinal illness, including painful symptoms in conjunction with internal bleeding in connection with H&NATURAL TejoRoot, and has not received any reports of adverse events in connection with H&NATURAL Brazil Seed.

Risk Statement: Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

The recalled dietary supplements can be identified by the H&NATURAL logo and the following descriptions:
- Tejo Root, Raiz de Tejocte, H&Natural, Healthy, and Natural, Dietary Supplement, 10g pills, is packaged in a box or bottle, with UPC (196852946921)
- Brazil Seed Pure Natural Semilla de Brasil, H& Natural, Healthy and Natural, 0.167g seeds, packaged in a box or bottle, with UPC (195893047529) (196852820641) (195893698721) (195893236893)(196852134618) (195893336975)

Recalled lots are labeled with the following expiration dates, 3/24 and 5/24.

Consumers that have the recalled H&NATURAL TejoRoot or H&NATURAL Brazil Seed lots should stop using the products. 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.

In case you experience harm from extraneous materials, 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: G.A. Mart dba H&Natural
Brand name: H&Natural
Product recalled: Brazil Seed Pure Natural Semilla de Brasil & Tejo Root, Raiz de Tejocte
Reason of the recall: Product contains yellow oleander, a poisonous plant
FDA Recall date: February 23, 2024

Source: fda.gov
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Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid. This recall is being conducted due to a manufacturing error that resulted in an elevated level of Vitamin D3 dosage or super potent dose. There have been no reports of adverse events to... See More date related to the use of this recalled product.

The recalled lot of Nordic Naturals Baby’s Vitamin D3 Liquid is 0.76 fl. oz. (22.5 mL), 400 IU (10mcg) D3. The affected lot number is 234909, with an expiration date of December 2025. The affected product is used as a dietary supplement for infants up to 12 months of age and is packaged in boxes containing one bottle and one dropper for dosage, under SKU RUS-02733. Approximately 3,800 units of product were affected, with one-fifth already returned by retailers.

Prolonged use of the recalled Baby’s Vitamin D3 Liquid could potentially lead to elevated vitamin D levels, resulting in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants.

Consumers, distributors, and retailers in possession of the recalled product should discontinue use immediately and return it to the place of purchase for a refund or replacement. The lot number can be found on the back of the box and on the bottle.

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.

Company name: Nordic Naturals
Brand name: Nordic Naturals
Product recalled: Baby’s Vitamin D3 Liquid
Reason of the recall: Elevated level of Vitamin D3 dosage
FDA Recall date: February 19, 2024

Source: fda.gov
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“Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil. Products were distributed online nationwide in the USA. To date, no... See More adverse events have been reported.

Tadalafil and Nortadalafil (structurally similar to Tadalafil) are active drug ingredients known for treatment of male erectile dysfunction. The presence of Tadalafil and Nortadalafil in Sustain capsules and Schwinnng capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged and coded as follows:
SUSTAIN: BTH: 230551 having EXP:12.05.2026, BTH: 230571 having EXP: 14.05.2026 SCHWINNNG Lot 2108 having EXP 10/2024.

The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products. Consumers that have Sustain or Schwinnng which is being recalled should stop using and return if desired to Today The World. The Sustain and Schwinnng products must include the blister pack foil (with any pills remaining) containing all lot codes and receipt of proof of purchase, and your return address.

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.

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: Today the World
Brand name: Sustain, Schwinnng
Product recalled: Sustain and Schwinnng brand male enhancement capsules
Reason of the recall: Products contain undeclared Tadalafil and Nortadalafil
FDA Recall date: February 05, 2024

Source: fda.gov
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"Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared Nortadalafil. The product was distributed online via their website in the USA. To date, no adverse events have been reported.... See More

Nortadalafil (structurally similar to Tadalafil) is an active drug ingredient known for treatment of male erectile dysfunction. The presence of Nortadalafil in Arize makes this an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as Attached. The product can be identified by –black box with the word Arize written in red on the front with a line underneath which reads: “For a rise that is hard to forget”.

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.

In case you experience 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: Today the World
Brand name: Arize
Product recalled: Arize brand male enhancement capsules
Reason of the recall: Products contain undeclared Nortadalafil
FDA Recall date: February 05, 2024

Source: fda.gov
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Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and... See More trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, which you can see in the link below. Customers who received the listed lots were given instructions to:
1. QUARANTINE affected kits/trays.
2. ALERT clinicians of the recalled component(s).
3. AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
4. NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.
5. RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product.

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.

Company name: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Expanded list of Urology and OR room specific kits and trays
Reason of the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: February 05, 2024

Source: fda.gov
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Insight Pharmaceuticals is voluntarily recalling two lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid to the consumer level due to elevated levels of benzene. The affected TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid lots were distributed nationwide in the United States through... See More a limited number of retailers and online. No serious adverse events have been reported to date.

TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid is packaged in blue and white aerosol cans with Lot codes located on the bottom of the can. Samples of the recalled lots below have been found to contain elevated levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.

- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 0H50545, Expiration Date: 07/24, Package Size: 4.5 oz/128 g.
- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 1G50645, Expiration Date: 06/25, Package Size: 4.5 oz/128 g.
Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid marked with one of the lot codes in the table above.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

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.

Company name: Insight Pharmaceuticals
Brand name: TING®
Product recalled: 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid
Reason of the recall: Presence of benzene
FDA Recall date: February 02, 2024

Source: fda.gov
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Neptune Resources, LLC issues a voluntary recall of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets Products Due to the Presence of Tianeptine. The products were distributed nationwide in the USA to wholesale and retail customers. Neptune Resources LLC's distribution channels have not... See More reported any adverse events from the use of its products.

The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use. Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening.

Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a "shrink sleeve" label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune's Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune's Fix products are being recalled. The product can be identified by the name Neptune's Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident.

Neptune Resources is notifying its distributors and customers by form of a mailed out recall letter and is arranging for the return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using it and return it to place of purchase immediately.

In case you experience 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: Neptune Resources, LLC
Brand name: Neptune’s Fix
Product recalled: Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets
Reason of the recall: Undeclared Tianeptine
FDA Recall date: January 29, 2024

Source: fda.gov
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Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found... See More tablets of Carbinoxamine Maleate, an antihistamine drug. The product was distributed nationwide through pharmacies. To date, Azurity has not received any reports of serious adverse events related to this recall.

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).

Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc.

Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Following are the details of the recalled product:

- Product: Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg, NDC No.: 24338-856-03, Lot No.: F230169A, Exp. Date: 2025-06, Ship Dates to Wholesalers: 08/23/2023 – 11/29/2023.

Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers who have a product that is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product.

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.

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.

Company name: Azurity Pharmaceuticals, Inc.
Brand name: Zendedi
Product recalled: dextroamphetamine sulfate tablets, 30 mg
Reason of the recall: Mislabeled package
FDA Recall date: January 25, 2024

Source: fda.gov
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Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. To date, Haleon has not received any reports of adverse events related to this... See More recall.

In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out.

Robitussin Honey CF Max Day and Nighttime are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies. This recall covers only the following lots:
- Product: ROBITUSSIN HONEY CF MAX DAY ADULT 4OZ, Lot Number: T10810, Expiry Date: 31OCT2025.
- Product: ROBITUSSIN HONEY CF MAX DAY ADULT 8OZ, Lot Number: T08730, T08731, T08732, T08733, T10808, Expiry Date: 31MAY2025, 31MAY2025, 31MAY2025, 31MAY2025, 30SEP2025.
- Product: ROBITUSSIN HONEY CF MAX NT ADULT 8OZ, Lot Number: T08740 and T08742, Expiry Date: 30JUN2026 and 30JUN2026.

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers who have purchased the product listed should stop consumption immediately.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

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.

Company name: Haleon
Brand name: Robitussin
Product recalled: Cough syrups
Reason of the recall: Microbial Contamination
FDA Recall date: January 24, 2024

Source: fda.gov
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