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.
Walmart is recalling Avaphinal Maximum Male Enhancement Sexual Pills (2000 MG, 10-capsule cartons, Lot DK1027) distributed nationwide because they contain undeclared sildenafil, making them an unapproved drug.
Family Pharmacy of Statesville is recalling Morphine Sulfate 6 mg/mL infusions in 250 mL bags due to lack of assurance of sterility. The affected product was distributed in North Carolina.
Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.
Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.
Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes (Lot #07282020@3) distributed in North Carolina because the manufacturer cannot assure the product meets sterility standards.
Swanson Health Products is recalling Swanson Ultra Vitamin B12 Methylcobalamin supplements due to potential metal shavings in the product. The contamination poses a choking and injury risk.
Family Pharmacy of Statesville is recalling Trimix injectable vials (Alprostadil/Papaverine/Phentolamine 20 mcg/30 mg/0.5 mg) due to lack of assurance of sterility. The recall affects 2 vials distributed in North Carolina.
Golden State Medical Supply Inc. is recalling Alprazolam Tablets, USP 1mg (180-count bottles, Lot #GS027852) due to potential cross-contamination with other drug substances during manufacturing.
The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg due to failed impurity and degradation specifications detected during routine stability testing. The recall affects 5,953 cartons distributed nationwide.
Acme United is recalling PhysiciansCare brand over-the-counter pain relievers and aspirin because the packaging is not child-resistant as required by law, creating a poisoning risk for young children.
American Health Packaging is recalling one lot of Oxycodone Hydrochloride Oral Solution due to impurity failure detected at initial testing of the repackaged product.
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.
The Harvard Drug Group is recalling 174 cartons of Paliperidone Extended-Release Tablets, 9 mg, nationwide due to failed dissolution specifications. The affected lots are N00522 (Exp. 09/2022) and N00618 (Exp. 11/2022).
Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.
TSM Brands LLC is recalling 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen due to undeclared ethyl alcohol in the product. The recall affects bottles distributed nationwide.
Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol bottles nationwide because the product contains undeclared ethyl alcohol that is not identified on the label.
Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.
Dollar Tree Distribution is recalling all over-the-counter drug products sold by Family Dollar retail stores in six states due to potential rodent exposure at a distribution center.
Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.
Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Morton Grove Pharmaceuticals is recalling Dexamethasone Elixir USP 0.5 mg/5 mL nationwide due to unknown impurities found at higher than permissible levels in affected lots.
HEB 50% Isopropyl Alcohol First Aid Antiseptic bottles contain 3% Hydrogen Peroxide instead due to a label mix-up. The front label incorrectly identifies the product as isopropyl alcohol when the contents are actually a hydrogen peroxide topical solution.
RISE UP RED EDITION Capsules, 650 mg, have been recalled because they contain undeclared tadalafil, an ingredient found in FDA-approved male sexual enhancement products. The product is an unapproved drug and was distributed nationwide via Amazon Marketplace.
Perrigo Company PLC is recalling Rugby Children's Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that had been recalled from the supplier.
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