FDA Drug Alerts

FDA DRUG ALERTS

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Audience: Healthcare Provider, Pharmacy, Consumer Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for...

FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies

Audience: Health Professional April 18, 2024 -- In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell malignancies including chimeric antigen receptor CAR-positive...

Counterfeit Versions of Botox Found in Multiple States

Audience: Health Care Professionals, Consumers April 16, 2024 -- FDA is alerting health care professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in multiple states and administered to...

Otsuka Initiates Voluntary Nationwide Recall of Certain Lots of Abilify (aripiprazole) Tablets Due to Drug Product Cross-Contamination on Manufacturing Equipment

Audience: Healthcare Provider, Pharmacy, Consumer PRINCETON, N.J. (April 9, 2024) – Otsuka America Pharmaceutical, Inc. (Otsuka) is voluntarily recalling certain Abilify (aripiprazole) Tablets in the United States due to cross-contamination...

Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel Due to Presence of Methanol

Audience: Consumers April 5, 2024 – Oranjestad, Aruba, Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to...

ForeverMen Supplements Recalled

Audience: Consumers April 2, 2024 -- FAonline INC , 65-20 180 Street NY 11365 is voluntarily recalling all lots within expiry of the ForeverMen capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and...

AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination

Audience: Consumer, Health Professional, Pharmacy March 29, 2024 –AvKARE, LLC is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in...

Eugia US LLC Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL Due to Presence of White Particles

Audience: Health Professional, Pharmacy March 28, 2024– East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL)...

Amneal Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL Due to the Potential for Some Bottles to be Super Potent

Audience: Consumer, Health Professional, Pharmacy March 27, 2024 - Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL...

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects

Audience: Consumers March 26, 2024 -- The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain...

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