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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.
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.
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.
Teva Pharmaceuticals recalls Azacitidine for Injection in Ohio after stability testing revealed the drug potency fell below specification standards.
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.
GenTeal eye ointment (40 boxes, nationwide) recalled due to CGMP storage deviations. Products were stored outside drug label specifications.
McKesson Medical-Surgical is recalling Bisacodyl suppositories stored outside label specifications. The FDA Class II recall affects 45 boxes distributed nationwide.
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.
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.
McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.
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.
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.
Nationwide recall of Ativan (lorazepam) injection lot 060064Z due to out-of-specification impurities and degradation products. Patients should contact their healthcare provider.
McKesson is recalling Dynarex Alcohol Swabsticks nationwide because products were stored outside the conditions specified on the drug label.
McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.
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.
Distributor RFR, LLC is recalling SANGTER Energy Supplement Capsules because FDA analysis found they contain undisclosed sildenafil without FDA approval. The product was distributed nationwide and internationally.
SUSTANGO capsules contain the undisclosed pharmaceutical ingredient tadalafil and were marketed without FDA approval. Approximately 750 cartons were distributed nationwide via Amazon.
Tolmar Inc. recalls Naftifine Hydrochloride Gel 1% due to out-of-specification impurity test results. The recalled tubes may contain unidentified impurities that exceed acceptable limits.
Teva Pharmaceuticals is recalling Matzim LA (Diltiazem Hydrochloride) 180 mg tablets because they failed to meet dissolution specifications. The recall affects approximately 8,022 bottles distributed nationwide in the United States and Puerto Rico.
The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Combo Pack because the acidified/low acid dietary supplement was manufactured without an FDA-approved process.
Matzim LA Extended-Release Tablets, 240 mg are being recalled due to failed dissolution specifications. Patients taking this medication should consult their doctor about their treatment.
The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Daytime dietary supplement due to use of an unapproved acidification process. The product was distributed to 42 states in approximately 34,526 cases.
The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Nighttime due to manufacturing without an approved acidification process. The product's preservation safety cannot be assured.
Glenmark Pharmaceuticals is recalling Tacrolimus Ointment 0.1% because tubes may split at the side seam. The recall affects over 654,000 units distributed nationwide.
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