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.
Azurity Pharmaceuticals is recalling 2,751 kits of Firvanq (vancomycin hydrochloride for oral solution) distributed nationwide because an incorrect diluent component was included in the kit.
ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.
Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.
Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 50) due to the presence of benzene contamination. The recall affects 1,437,804 aerosol cans distributed nationwide.
IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.
IntegraDose Compounding Services LLC is recalling ceFAZolin 2 G/20 mL sterile syringes for injection due to lack of sterility assurance. Approximately 2,614 syringes distributed in NH, MA, and MN are affected.
Jacobus Pharmaceutical Company is recalling Ruzurgi (amifampridine) 10 mg tablets due to microbial contamination. Testing found that certain lots exceeded acceptable limits for aerobic bacteria, yeast, and mold.
Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) in 8.5 oz aerosol cans due to the presence of benzene contamination.
Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.
New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.
Washington Homeopathic Products is recalling Quebracho 4C Fever homeopathic medicine (Lot #28930, expiration 8/17/2026) distributed nationwide due to out-of-specification test results from identification testing.
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.
Washington Homeopathic Products, Inc. is recalling ZTE-1034 Formula Antimicrobial Bowel (1000ml bottles) due to out-of-specification test results in identification testing. The product was distributed nationwide.
Washington Homeopathic Products is recalling Althaea 30X Irritable Bladder sucrose/lactose pills (Lot #29377, expiration 8/17/2026) distributed nationwide because testing revealed out-of-specification results for product identification.
Washington Homeopathic Products is recalling 562 bottles of Aconitum Napellus Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing.
Washington Homeopathic Products is recalling Althaea Officinalis 4X, Iritable Bladder homeopathic medicine (Lot # 29377, Exp 8/17/2026) distributed nationwide because testing results failed to meet specifications for product identification.
Washington Homeopathic Products is recalling Z-103 GU DETOXING, a 1000ml homeopathic medicine containing 20% alcohol, due to out-of-specification test results on identification testing using HPTLC analysis.
Monarch PCM, LLC is recalling Ferretts IPS Iron Liquid Dietary Supplement because stability testing shows the product degraded to 81% potency over a 3-month period, falling below specification limits.
Washington Homeopathic Products is recalling Aconitum nap Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing. The recall affects 562 bottles across multiple potencies and lot 26198.
Washington Homeopathic Products is recalling Yeast Guard Blend homeopathic medicine because test results show it does not meet specification requirements for identification testing.
Washington Homeopathic Products is recalling Cinnamomum 6X and 30X homeopathic pills due to failed identification testing results. The products did not meet specifications in HPTLC analysis.
Johnson & Johnson Consumer, Inc. is recalling Aveeno Protect + Refresh sunscreen weightless spray SPF 60 nationwide due to cGMP (current good manufacturing practice) deviations.
Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 70 (5.0 oz aerosol cans) due to cGMP manufacturing deviations. The product was distributed nationwide.
Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.
Johnson & Johnson Consumer, Inc. is recalling 405,264 cans of Neutrogena COOLDRY SPORT Broad Spectrum SPF 100 sunscreen spray nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary recall initiated by the firm.
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