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.
Glenmark Therapeutics is recalling famotidine 20 mg tablets after some cartons were labeled with a side label indicating 10 mg instead. The medication inside is correct; only the external carton label is mislabeled.
Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.
Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.
EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.
L. Perrigo Company is recalling Picnic Fexofenadine Hydrochloride Tablets (180 mg) nationwide because the product failed impurity and degradation specifications. The affected lot is 2DR0471 with expiration date 12/23.
L. Perrigo's Allergy Relief 180 mg tablets are being recalled due to failed impurity and degradation specifications. The recall affects 32,904 cartons distributed nationwide.
EzriCare Artificial Tears eye drops are being recalled nationwide due to manufacturing facility contamination and CGMP deviations. The recall includes multiple lot numbers distributed nationwide.
Accord Healthcare is recalling Bivalirudin for Injection lot M2212070 due to the presence of fiber particles. Bivalirudin is an injectable blood thinner used in cardiac procedures.
BASIC CARE ALLERGY (fexofenadine hydrochloride) 180 mg tablets are being recalled nationwide due to failed impurities and product degradation specifications. Approximately 11,904 cartons were affected.
Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.
Big Machine Distillery Hand Sanitizer is being recalled due to manufacturing impurities exceeding allowable limits. No illnesses or injuries have been reported.
CVS Pharmacy is recalling 16,200 cartons of Allergy Relief fexofenadine hydrochloride tablets nationwide due to failed impurities and degradation specifications. Stop using affected lot 2DV1925 and consult a pharmacist.
Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.
Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.
K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark and generic tetrahydrozoline eye drops due to manufacturing practice deficiencies. The recall affects multiple brands distributed nationwide.
B. Braun Medical Inc. is recalling 79,880 bags of Sodium Chloride Injection due to potential leakage that could compromise sterility. No illnesses or injuries have been reported.
L. Perrigo Company is recalling 15,504 cartons of Fexofenadine Hydrochloride 180 mg tablets nationwide due to failed impurity and degradation specifications.
L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.
L. Perrigo Company is recalling Berkley Jensen Allergy Relief tablets due to failed product quality specifications involving impurities and degradation. Consumers should verify their lot numbers and expiration dates.
Accord Healthcare is recalling Atropine Sulfate Injection due to the presence of particulate matter identified as fiber. Two lots totaling 2,348 vials have been distributed nationwide.
Teva Pharmaceuticals is recalling 180 bottles of Sunitinib Malate Capsules due to moisture content exceeding approved specifications. The affected lot (100037220) expires 10/2024.
L. Perrigo Company is recalling 1,920 cartons of Exchange Select Aller Ease (Fexofenadine Hydrochloride) 180 mg tablets nationwide due to failed impurity and degradation specifications.
Vivus, Inc. is recalling Pancreaze delayed-release capsules nationwide due to failed stability specifications. The affected lot may not maintain product strength through the stated expiration date.
Target's store-brand fexofenadine allergy relief tablets are being recalled nationwide due to failed quality specifications for impurities and degradation. Consumers should stop using affected lots and contact Target or their healthcare provider.
K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.
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