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.
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.
Tailor Made Compounding is recalling 220 vials of Pentosan Polysulfate Sodium due to lack of assurance of sterility. The affected batches were distributed nationwide in the United States and Puerto Rico.
Tailor Made Compounding is recalling 106 vials of compounded testosterone/anastrozole injectable due to lack of sterility assurance. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 414 vials of Testosterone Enanthate 200mg/ml (5 mL and 10 mL) due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling Methylcobalamin Preservative Free 10mg/mL injectable due to lack of assurance of sterility. The affected batch may not meet sterility standards required for injectable medications.
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.
Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
TMC Acquisition LLC is recalling Alpha Lipoic Acid 25mg/mL vials due to lack of assurance of sterility in manufacturing. The product was distributed nationwide.
TMC Acquisition LLC is recalling testosterone injectable products (58 vials) distributed nationwide and to Puerto Rico due to lack of assurance of sterility in manufacturing.
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine injectable distributed nationwide because the manufacturer cannot assure the product meets sterility standards. Patients should stop using the recalled product and contact their healthcare provider.
Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
Tailor Made Compounding recalls Glutathione 200mg/mL injectable vials due to lack of sterility assurance. The FDA Class II recall affects 40 vials distributed nationwide.
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.
Sun Pharmaceutical recalls 50,860 vials of Testosterone Cypionate Injection due to water leakage during manufacturing that could affect product sterility. The firm-initiated recall was reported in July 2022 and affects nationwide distribution.
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.
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.
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.
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.
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