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.
Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.
STAQ Pharma is recalling ROPivacaine HCl 0.2% injection bags nationwide due to leaking bags caused by manufacturing quality control failures. No illnesses or injuries have been reported.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
Right Value Drug Stores is recalling LET Gel topical anesthetic syringes nationwide due to incorrect product formulation. Patients should not use affected syringes and should consult their healthcare provider.
Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.
Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.
Botanical Be is recalling Kuka Flex Forte caplets nationwide because they contain undeclared diclofenac and were marketed without required FDA approval. All lots expire 12/12/2024.
Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.
Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.
Apotex Corp. is recalling Paroxetine 10 mg tablets nationwide due to out-of-specification impurities in an excipient. Affected lots expire 08/2024.
Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.
Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.
Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.
Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.
VistaPharm LLC is recalling Aminocaproic Acid Oral Solution (0.25 grams/mL) distributed nationwide due to high ethylene glycol content from failed manufacturing specifications. Four lot numbers are affected.
Golden State Medical Supply is recalling certain lots of Paroxetine 20 mg tablets nationwide due to an out-of-specification chemical impurity in the product.
Teva Pharmaceuticals recalls specific lots of Testosterone Gel 1.62% for failing viscosity specifications. Patients should contact their healthcare provider to discuss the recall and obtain unaffected medication.
Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.
Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets due to failed impurity specifications. A total of 5,626 bottles were distributed nationwide.
Fagron Compounding Services is recalling 756 bottles of compounded ophthalmic medication because labels incorrectly identify the container as a 0.5mL single-use syringe instead of a 5mL dropper bottle. No adverse events have been reported.
Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.
FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.
Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.
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