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.
Golden State Medical Supply is recalling 31,260 bottles of Enalapril Maleate Tablets due to manufacturing practice deviations.
Wedgewood Village Pharmacy LLC is recalling Doxycycline oral suspension (10 mg/ml, 60 ml bottles) nationwide due to insanitary conditions and lack of processing controls discovered during FDA inspection.
Wedgewood Village Pharmacy is recalling Bethanechol Chloride 1mg/ml suspension (lot 000-03715131) due to insanitary conditions and lack of processing controls observed during an FDA inspection.
Golden State Medical Supply Inc. is recalling Enalapril Maleate 2.5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 1,471 bottles were distributed nationwide.
Macleods Pharma USA Inc is recalling Eszopiclone 1 mg tablets due to shortfill—customers reported one to three missing tablets from 30-count bottles. Affected lot BEK2009A (exp. 11/2023) was distributed nationwide and to Puerto Rico.
Sun Pharmaceutical is recalling 27 vials of Testosterone Cypionate Injection (200 mg/mL) due to manufacturing deviations caused by abnormal machinery appearance. The recall affects multiple lot numbers distributed nationwide.
Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units distributed nationwide.
Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.
Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.
Allergy Bee Gone for Kids Nasal Swab Remedy is recalled due to FDA-confirmed microbial contamination including yeast, mold, and Bacillus cereus. Affected consumers should stop using the product.
Akcea Therapeutics recalls certain Tegsedi (inotersen) Injection lots due to higher-than-labeled active ingredient content. Affected lots were distributed in Kentucky.
SnoreStop NasoSpray nasal spray has been recalled due to bacterial contamination. FDA analysis identified Providencia rettgeri in the product.
PD-Rx Pharmaceuticals recalled Losartan Potassium 50 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. The recall affects 687 bottles across multiple lots.
Daytrana (methylphenidate) patches are being recalled due to ripping patches and poor adhesive transfer affecting drug delivery. This Class II recall involves 8,559 cartons distributed nationwide.
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.
PD-Rx Pharmaceuticals recalls Losartan Potassium Tablets (25 mg, 90-tablet bottles) due to Current Good Manufacturing Practice deviations. Specific lot numbers contain AZIDO impurity levels above acceptable limits.
Akorn, Inc. is recalling 44,400 bottles of Fluticasone Propionate Nasal Spray nationwide due to a defective container that prevents proper dispensing. Patients should contact their healthcare provider or pharmacist.
PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.
Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.
Akorn, Inc. is recalling Calcipotriene Topical Solution 0.005% (Scalp Solution) nationwide due to a defective delivery system that could prevent the product from dispensing properly.
Mohnark Pharmaceuticals is recalling Lidocaine 4% Topical Anesthetic Cream because the packaging does not meet child-resistant requirements, creating a poisoning risk if young children ingest the product. About 9,000 units sold online were affected.
Sun Pharmaceutical recalls 97,450 vials of Testosterone Cypionate Injection nationwide due to manufacturing deviations that could cause out-of-specification impurities.
Sun Pharmaceutical is recalling approximately 47,500 vials of Testosterone Cypionate Injection due to a manufacturing deviation that may have affected product sterility.
Vi-Jon's 70% isopropyl alcohol bottles may leak when squeezed or tilted due to defects in the bottle neck finish. Over 3 million bottles with various lot numbers were distributed nationwide.
Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets (0.125mg) due to manufacturing defects where oversized tablets were found. The affected lot (MHC1430A, exp. 09/2023) was distributed nationwide.
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