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.
Hikma Pharmaceuticals is recalling Lorazepam Injection vials due to out-of-specification impurities and degradation products found during quality testing of retained samples.
SterRx is recalling 360 bags of fentanyl citrate IV medication due to lack of assurance of sterility. No illnesses have been reported.
McKesson Medical-Surgical Inc. is recalling Triple Antibiotic Ointment due to storage deviations that violated drug label specifications and current good manufacturing practices.
SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.
Hikma Pharmaceuticals is recalling approximately 4.7 million vials of Lorazepam injection nationwide after finding out-of-specification related compounds during quality testing. The affected lots expire between June and August 2023.
Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.
Mckesson Medical-Surgical has recalled Eye-stream eye wash solution nationwide due to storage conditions outside drug label specifications.
ZADITOR eye drops were stored outside FDA label specifications in a nationwide Class II recall affecting 9 boxes distributed by McKesson Medical-Surgical Inc.
Strides Pharma is recalling Prednisone 20 mg tablets due to contamination with 2.5 mg tablets. No illnesses have been reported, but patients may receive incorrect doses.
A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.
Teva Pharmaceuticals recalls Azacitidine for Injection in Ohio after stability testing revealed the drug potency fell below specification standards.
Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.
The FDA recalled 67 bottles of Miralax laxative powder due to storage conditions that violated drug label specifications. The precautionary recall is due to potential product quality concerns from improper storage conditions.
McKesson is recalling Dynarex Alcohol Swabsticks nationwide because products were stored outside the conditions specified on the drug label.
Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.
Mckesson Medical-Surgical is recalling Pataday Once Daily Relief eye drops nationwide because the products were stored outside label specifications. No illnesses have been reported.
GenTeal eye ointment (40 boxes, nationwide) recalled due to CGMP storage deviations. Products were stored outside drug label specifications.
SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.
McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.
Nationwide recall of Ativan (lorazepam) injection lot 060064Z due to out-of-specification impurities and degradation products. Patients should contact their healthcare provider.
Mckesson Medical-Surgical is recalling S2 Racepinephrine Inhalation Solution due to storage that deviated from label specifications. This Class II recall affects 23 cartons distributed nationwide.
McKesson Medical-Surgical is recalling Bisacodyl suppositories stored outside label specifications. The FDA Class II recall affects 45 boxes distributed nationwide.
Glenmark Pharmaceuticals recalls 72,288 units of Telmisartan-Hydrochlorothiazide 80/25 mg tablets nationwide due to defective blister packaging that is difficult to open and causes tablets to break.
AVKARE Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg nationwide due to a labeling error in the declared strength.
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Telmisartan and Hydrochlorothiazide tablets due to complaints of defective blister packs that are difficult to open and cause tablets to break during removal.
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