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.
Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.
Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.
Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.
Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.
Macleods Pharmaceuticals is recalling Olanzapine 2.5 mg tablets nationwide due to failed impurities and degradation specifications. The recall affects one production lot distributed across the United States.
Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.
Provepharm Inc. is voluntarily recalling Dihydroergotamine Mesylate Injection nationwide due to discoloration in specific lots. Patients should contact their healthcare provider if they have used the affected product.
Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released to customers.
Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.
Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.
Viatris Inc is recalling Levothyroxine Sodium 100 mcg tablets for potency failures causing some tablets to be too strong and others too weak. Approximately 65,169 units are affected nationwide.
Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.
Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.
Viatris Inc is recalling Levothyroxine Sodium Tablets 25 mcg nationwide due to potency failures. Some tablets are superpotent while others are subpotent, which could affect medication effectiveness.
Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.
DesBio lunaSOMM Natural Sleep Support Dietary Supplement is recalled due to undeclared soy lecithin. The product is labeled as containing sunflower lecithin but contains soy lecithin, posing a risk to consumers with soy allergies.
Mylan Institutional recalls levothyroxine sodium tablets (lot 3115707) due to subpotent and superpotent tablets. The product was distributed nationwide. Consult your healthcare provider.
Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.
Mylan Institutional recalls 1,133 cartons of Levothyroxine Sodium Tablets (137 mcg) nationwide. Three lots contain subpotent and superpotent tablets.
Viatris Inc. is recalling 42,331 bottles of Levothyroxine Sodium Tablets 50 mcg distributed nationwide due to potency failures resulting in both superpotent and subpotent tablets.
Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.
Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 137 mcg due to potency failures in some tablets being stronger or weaker than specified. The recall affects 118,324 bottles distributed nationwide in the United States and Puerto Rico.
Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.
Mylan Institutional is recalling 1,664 cartons of levothyroxine sodium tablets nationwide due to potency variance. The tablets contain subpotent and superpotent units, affecting the consistency of each dose.
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