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.
Pyramids Wholesale Inc. is recalling HONEY MANUKA BUNNY LOVE nationwide because it contains undeclared sildenafil and/or tadalafil—prescription medications—and was marketed without FDA approval.
Samurai-X Honey 6800, manufactured by Pyramids Wholesale Inc., is recalled for containing undeclared sildenafil and/or tadalafil. The product was distributed nationwide and marketed without FDA drug approval.
Nomax Inc is recalling GloStrips fluorescein sodium ophthalmic strips nationwide due to failure of the active pharmaceutical ingredient to meet USP standards for unspecified impurities.
The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips (4,648 cartons) nationwide due to unspecified impurities in the active ingredient exceeding USP standards.
EPI Health is recalling minolira extended-release tablets due to manufacturer discontinuation of quality control programs affecting product identity, strength, and purity. The recall covers 12,808 bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to failure to meet dissolution specifications. The affected lot may not release the medication properly in the body.
Cipla USA recalls Ipratropium Bromide and Albuterol Sulfate inhalation solution due to short fill in unit-dose vials. Some vials contain less medication than labeled, affecting dosage.
EPI Health is recalling 5,664 bottles of minolira tablets because the manufacturer discontinued its quality assurance program. Affected lots include T2201700 and T2201701, distributed nationwide.
FDA recalls GloStrips (Fluorescein Sodium) ophthalmic strips due to manufacturing defects in the active pharmaceutical ingredient. The API does not meet current USP purity standards for unspecified impurities.
EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.
ABILIFY (aripiprazole) 15 mg tablets from lot AMS00223A are being recalled due to cross contamination with other products. The recall affects packages distributed nationwide.
Certain lots of Abilify (aripiprazole) 10 mg tablets are being recalled due to cross-contamination with other products. Affected products were distributed nationwide.
Nomax Inc recalls FUL-GLO Fluorescein Sodium Ophthalmic Strips (Lot 14776) nationwide due to API manufacturing specification failures. The active ingredient was not manufactured to current USP standards regarding unspecified impurities.
Otsuka America Pharmaceutical is recalling certain lots of Abilify (aripiprazole) 5 mg tablets distributed nationwide due to cross contamination with other products. This is classified as a Class III recall.
Honeywell Inc. is recalling FENDALL 2000 PURE FLOW eyewash solution due to Current Good Manufacturing Practice deviations. The recall affects 10,605 cartridges distributed nationwide in the USA and Canada with expiration dates through June 2025.
Abilify (aripiprazole) 30mg tablets are being recalled due to cross-contamination with other products. The affected lots were distributed nationwide in the United States.
HandNatural's H&Natural Brazil Seed dietary supplement is being recalled due to the presence of yellow oleander, a toxic plant component. Distribution was exclusively through internet sales.
AvKARE recalls Atovaquone Oral Suspension due to potential Bacillus cereus contamination of a non-sterile product. The recalled lot (AW0221A, Exp. 08/30/2025) was distributed nationwide; 153 cartons affected.
Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.
Eli Lilly & Company has voluntarily recalled 700 vials of Humalog sterile diluent due to Current Good Manufacturing Practice (CGMP) deviations. The affected batch (D608951C, exp. 4/10/2025) was distributed nationwide.
Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.
Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.
Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.
Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.
Eugia US LLC is recalling Methocarbamol Injection nationwide due to particulate matter contamination. The FDA classified this as a Class I recall affecting lot 3MC23011 (expiration 11/30/2026).
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