Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.
B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.
Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.
ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.
Fagron Compounding Services is recalling Lidocaine HCl Injection due to lack of assurance of sterility. Four lot numbers distributed nationwide are affected with expiration date 10/14/2024.
FDC Limited recalls Timolol Maleate Ophthalmic Solution nationwide because the bottle cap spike becomes lodged in the nozzle, preventing patients from dispensing the medication. No illnesses have been reported.
HAND-I-SAN No-Rinse Hand Sanitizer is being recalled due to manufacturing process deviations involving the use of non-sterile water in production. The product was distributed nationwide and to Canada.
FDC Limited recalls Timolol Maleate eye drops (362,544 bottles) nationwide due to a manufacturing defect: a yellow spike from the cap lodged in the nozzle, posing a risk of eye injury.
Taro Pharmaceuticals recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution (lot AD12890) due to failed impurity specifications and lower-than-established active ingredient levels during stability testing.
Some bottles of Acetaminophen Extra Strength 500 mg tablets are labeled with the drug facts information for Aspirin 81 mg tablets. The affected lot is 4138197 (expiration 10/31/2025), distributed nationwide.
Umary Acido Hialuronico dietary supplement (850 mg caplets) was recalled nationwide by the FDA for containing undeclared Diclofenac and Omeprazole. The product was marketed without an approved drug application.
Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.
Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets 600 mg nationwide after fused Metformin ER tablets were found in bottles, creating a risk of unintended medication exposure.
A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.
Amneal Pharmaceuticals recalls Methotrexate 2.5mg tablets (Lot BB29124) distributed nationwide due to potential presence of Fludrocortisone Acetate tablets. Patients should verify their lot number with their pharmacy.
Walgreen Co. is recalling Acetaminophen 500mg Rapid Release Gelcaps (Lot #31670346AA, expires 12/31/2026) due to incorrect carton labeling. The 21,192 affected bottles were distributed to retailers in Illinois.
Dr. Reddy's Laboratories is recalling Sevelamer Carbonate for Oral Suspension packets missing lot number and expiration date information. Approximately 5,136 cartons were distributed nationwide.
SoloVital's Umary Hyaluronic Acid supplement was recalled because FDA testing found it contains undeclared Diclofenac and Omeprazole. The product, marketed without approved NDA/ANDA, affected 1,331 bottles distributed nationwide.
Endo Pharmaceuticals is recalling 8,139 cartons of Clonazepam Orally Disintegrating Tablets due to carton labeling errors. The carton labels incorrectly state 0.125 mg while the actual tablets inside contain 0.25 mg.
Amerisource Health Services LLC is recalling 61,231 bottles of Potassium Chloride Extended-Release Capsules nationwide due to failed dissolution specifications. The medication may not release properly, potentially affecting dosing accuracy.
Eugia US LLC is recalling Progesterone Injection vials nationwide due to glass particles found in the product. Patients and healthcare providers should stop using the affected lot.
Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.
NaturesPlus T-MALE liquid supplement is being recalled because the product is missing the key ingredient TongKat Ali and contains an additional ingredient, Rhodiola Rosea, that should not be present.
Natural Organics is recalling NaturesPlus ULTRA T-MALE due to incorrect formulation: the product is missing the ingredient TongKat Ali and contains additional Rhodiola Rosea. No illnesses have been reported.
FDC Limited is recalling 66,528 bottles of Ciprofloxacin ophthalmic solution USP 0.3% due to a manufacturing defect in the container cap that prevents access to the medication. All affected bottles were distributed nationwide.
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