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 Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding recalls two batches of Alprostadil/Papaverine/Phentolamine injectable due to lack of sterility assurance. The recall affects 32 vials distributed nationwide and in Puerto Rico.
Tailor Made Compounding recalls 41 vials of Testosterone Cypionate/Anastrozole due to lack of assured sterility. FDA Class II recall affects products distributed nationwide.
Tailor Made Compounding is recalling 63 vials of Hydroxocobalamin 25mg/mL injectable solution nationwide due to lack of assurance of sterility. Consumers should not use affected batches.
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 is recalling Teriparatide injectable syringes nationwide due to lack of assurance of sterility. Patients using affected batches should contact their healthcare provider immediately.
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.
Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been reported.
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.
Tailor Made Compounding has recalled 182 vials of Melanotan I injectable due to lack of assurance of sterility. The affected vials were distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.
TMC Acquisition LLC is recalling Calcium Chloride Preservative Free injectable solution in 5 mL and 30 mL vials due to lack of assurance of sterility. The recall affects 138 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.
Jubilant Draximage Inc. is recalling Draximage MAA, an injectable diagnostic drug kit, due to failed endotoxin testing. The recall affects 519 cartons distributed nationwide (Lot 1H005, expiration November 30, 2023).
Tailor Made Compounding recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.
TMC Acquisition LLC recalls 191 vials of Methylcobalamin 1mg/mL distributed nationwide and in Puerto Rico due to lack of sterility assurance. Consult your healthcare provider regarding any vials in your possession.
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