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.
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
Testosterone propionate injectable vials are being recalled due to lack of assurance of sterility. The recall affects product distributed nationwide in the USA and Puerto Rico.
CVS Hydrogen Peroxide Topical Solution bottles contain 70% isopropyl alcohol instead of the labeled hydrogen peroxide. The labeling error could lead to misuse and potential harm if consumers use the product as labeled.
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.
Tailor Made Compounding has recalled Vitamin D3 50,000IU/mL vials nationwide due to lack of sterility assurance during manufacturing. No illnesses have been reported.
CVS Health Magnesium Citrate SALINE LAXATIVE Oral Solution (1.745 g, Lemon Flavor, 10 FL OZ) is being recalled due to microbial contamination with Gluconacetobacter Liquefaciens. Approximately 98,958 bottles distributed nationwide are affected.
Wedgewood Village Pharmacy is recalling Estriol 1mg/gm Vaginal Cream due to insanitary manufacturing conditions and lack of adequate processing controls identified during FDA inspection. The product was distributed nationwide.
The FDA has recalled Boric Acid 600 mg capsules (Lot #000-03868160, Exp: 09/14/22) manufactured by Wedgewood Village Pharmacy due to insanitary conditions and lack of processing controls observed during FDA inspection. The recalled product was distributed nationwide.
Wedgewood Village Pharmacy is recalling Estriol vaginal cream nationwide due to insanitary manufacturing conditions and lack of processing controls identified during an FDA inspection.
Wedgewood Village Pharmacy is recalling Boric Acid 600 mg vaginal suppositories (Lot #000-03843532) nationwide due to insanitary manufacturing conditions and lack of processing controls detected during an FDA inspection. No illnesses have been reported.
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 is recalling 31,260 bottles of Enalapril Maleate Tablets due to manufacturing practice deviations.
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.
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.
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.
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.
Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units 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.
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.
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.
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 recalled Losartan Potassium 50 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. The recall affects 687 bottles across multiple lots.
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