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.
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.
Topcare Allergy Relief 180 mg tablets recalled for failed impurity and degradation specifications. The recall affects 44,280 cartons distributed nationwide.
L. Perrigo Company recalls Kirkland Signature Aller Fex allergy tablets nationwide due to certain lots failing impurities and degradation quality specifications. Consumers with affected lots should contact their healthcare provider.
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.
L. Perrigo Company is recalling approximately 59,688 cartons of Fexofenadine Hydrochloride 180 mg allergy relief tablets nationwide because the product failed to meet FDA specifications for impurities and degradation.
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.
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.
Lupin Pharmaceuticals recalls Amlodipine Besylate 10 mg tablets (Lot A102887) after stability testing revealed the tablets failed potency specifications, containing less active ingredient than labeled. Patients should contact their pharmacist or doctor.
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.
Strides Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, due to the presence of blue plastic pieces embedded in tablets from lot 7901903A. No illnesses or injuries have been reported.
Amerisource Health Services LLC recalls approximately 4,971 cartons of Tizanidine Tablets due to failed dissolution specifications. Tablets that do not dissolve properly may not provide intended therapeutic benefit.
Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.
The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.
Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.
Ferring Pharmaceuticals is recalling certain lots of Endometrin (progesterone) Vaginal Inserts due to potential microbial contamination resulting from manufacturing deviations.
Homeocare Laboratories recalls Kanjo Homeopathic Pain Relief Cream due to manufacturing process deviations. The recall affects 921 bottles distributed nationwide.
The FDA is recalling StellaLife VEGA Oral Care Rinse nationwide due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall.
DoloEar Earache Drops are being recalled due to manufacturing practice deviations. Homeocare Laboratories voluntarily initiated the recall, which was terminated in September 2024.
Homeocare Laboratories is recalling Arnica 7 Cream due to manufacturing standards deviations. The recall affects 2,376 bottles with lot number 2446.
StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.
Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets 50 mg nationwide due to inadequately sealed blister packaging. Affected lot M04343 (expiration 04/2024) may have compromised product integrity.
Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.
StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.
Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.
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