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.
Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.
Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.
Medline Industries is recalling convenience kits containing Huons Lidocaine HCL Injection USP 1% ampules due to quality issues identified during an FDA manufacturing inspection of the drug maker's site.
Blaine Labs Inc is recalling Tridergel wound care gel nationwide due to current good manufacturing practice (CGMP) deviations. The product was manufactured in a facility under the same conditions as contaminated product.
Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.
Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their expiration dates.
McKesson is recalling Gemcitabine Injection (1 g per 26.3 mL) due to temperature abuse—the product was stored at controlled room temperature instead of under refrigeration. The affected lot was distributed nationwide.
Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.
Medline Industries is recalling three convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons' facility.
Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) because the firm discontinued required stability testing for products still on the market within their expiration date.
Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg (90-tablet bottles) nationwide due to subpotency. The affected lot is D2401522 with expiration date 06/2026.
Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.
Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg due to manufacturing deviations involving incorrect detergent use and missing swab sampling.
Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fexofenadine Hydrochloride Tablets, USP 180 mg distributed nationwide because the product failed impurities and degradation specifications. The recall affects approximately 9,048 bottles distributed across the United States.
PReye LLC is recalling PReye Vitamin See Antioxidant Preservative Free Eye Drops distributed in Colorado due to lack of assurance of sterility. All unexpired lots are affected.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.
Central Admixture Pharmacy Services recalls a patient-specific pediatric TPN (Total Parenteral Nutrition) bag because it did not contain copper and famotidine as labeled.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal, compromising sterility assurance.
CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.
Annora Pharma is recalling Lacosamide 100mg tablets nationwide after discovering Selexipag 1000 mcg tablets mixed into bottles. Patients taking the wrong medication could experience unintended health effects.
Sun Pharmaceutical is recalling Perampanel 6 mg tablets due to labeling mix-up where 10 mg tablets were found in bottles labeled as 6 mg. Patients should verify their bottles with their pharmacy or physician.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal area, compromising sterility assurance.
Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets nationwide due to the presence of a foreign substance. Patients should consult their healthcare provider before stopping this medication.
Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.
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