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 Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.
Pfizer recalls 220,400 cartridges of Labetalol Hydrochloride injection due to potential incomplete crimp seals that could compromise sterility. Affected lots should not be used; healthcare providers should contact Pfizer for guidance.
Pacira Pharmaceuticals recalls Zilretta intra-articular injectable suspension nationwide after the product failed dissolution specifications in stability testing.
Contract Pharmacal Corporation is recalling 14,616 bottles of Extra Strength Acetaminophen 500mg tablets due to discoloration appearing as brownish tablets. The affected lot was distributed in Michigan.
NeilMed Pharmaceuticals is recalling 20,370 bottles of SinuFrin Quick Relief Decongestant (Lot SD134) nationwide due to sub-potency. No illnesses have been reported.
Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.
Consumer Product Partners is recalling Pure Petroleum white petrolatum products sold at Rite Aid, Kroger, Harris Teeter, and CVS nationwide because the products labeled as pure white petrolatum actually contain undisclosed lavender and chamomile.
Lupin Pharmaceuticals is recalling one lot of Cefixime oral suspension (200 mg/5 mL) due to failed content uniformity specifications. The recall affects 3,552 bottles distributed nationwide.
Teva Pharmaceuticals is recalling 34,448 bottles of Amoxicillin and Clavulanate Potassium Tablets USP (Chewable 400mg/57mg) distributed nationwide due to subpotency. The recall is voluntary and initiated by the firm.
Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.
OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.
Eugia US LLC is recalling 15,500 vials of Eptifibatide injection nationwide due to failed impurities and degradation specifications. The defect involves a related substance identified as Eptifibatide dimer.
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper contaminating the drug. The recall affects 2,806 vials distributed nationwide.
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper. Lot F1040001 was distributed nationwide.
Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.
Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.
RemedyRepack Inc. is recalling bottles labeled as Phenazopyridine HCl 100mg that actually contain Phenobarbital 16.2mg tablets. Eight bottles were distributed to one medical facility. Patients should not use these medications and must contact their healthcare provider.
Pacira Pharmaceuticals is recalling 43,768 kits of Zilretta injectable suspension due to failed stability specifications at 2–8°C storage for 12 months followed by 25°C for 6 weeks. No illnesses or injuries have been reported.
Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.
Organon LLC is recalling 2,551 units of ASMANEX Twisthaler mometasone furoate inhalation powder nationwide due to defective containers. Affected lot X024051 expires April 25, 2025.
Organon LLC is recalling Asmanex Twisthaler (mometasone furoate) inhalation powder nationwide due to defective containers. Affected lot #Y000085 expires April 25, 2025.
Organon LLC has voluntarily recalled 2,886 units of Asmanex inhalation powder nationwide due to defective containers.
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.
Glenmark Pharmaceuticals recalls Rizatriptan Benzoate 5mg tablets due to excess N-Nitroso Desmethyl Rizatriptan impurity. The nationwide recall affects 3,480 cartons with lots 19233788 and 19224445.
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