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.
Mckesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during distribution that may affect product quality and efficacy. Affected patches were distributed nationwide.
McKesson Medical-Surgical is recalling Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension due to manufacturing temperature control deviations. The recall affects 177 cartons distributed nationwide.
McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.
McKesson is recalling 9 vials of Duraclon (clonidine HCl) injection nationwide due to temperature deviations that violated current Good Manufacturing Practice (cGMP) standards.
Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.
McKesson Medical-Surgical is recalling Ketoconazole Cream 2% (60-gram tubes) distributed nationwide due to cGMP deviations involving temperature abuse during manufacturing.
McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage that may affect medication stability.
McKesson Medical-Surgical is recalling Triamcinolone Acetonide cream nationwide due to cGMP deviations related to temperature abuse during manufacturing. Specific lot numbers of affected product could not be identified.
The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.
McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.
McKesson is recalling doxycycline hyclate 100 mg tablets nationwide due to temperature abuse during manufacturing that fails to meet good manufacturing practice standards.
McKesson Medical-Surgical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) due to temperature abuse during manufacturing. The affected vials were distributed nationwide; patients should contact their healthcare provider.
McKesson Medical-Surgical is recalling Azithromycin for Injection 500 mg vials nationwide due to temperature control deviations identified during manufacturing.
McKesson Medical-Surgical is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.
Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.
Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.
Revonto (dantrolene sodium) injection is being recalled due to manufacturing deviations involving temperature abuse. Approximately 49 cartons were distributed nationwide; healthcare providers should contact their supplier for guidance.
Mupirocin Ointment distributed nationwide is being recalled due to temperature abuse violations during manufacturing. Consumers with affected supplies should contact their pharmacy or healthcare provider for guidance.
McKesson Medical-Surgical is recalling Lidocaine Patch 5% nationwide due to temperature abuse during distribution that may have compromised product quality. The FDA classified this as a Class II recall.
McKesson Medical-Surgical is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.
McKesson Medical-Surgical is recalling Lidocaine and Prilocaine Cream due to cGMP deviations involving temperature abuse during distribution. The recall affects 23 tubes distributed nationwide.
McKesson Medical-Surgical is recalling Arzol silver nitrate applicators nationwide due to temperature abuse during manufacturing that may affect product quality.
McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.
McKesson Medical-Surgical is recalling Naltrexone Hydrochloride 50 mg tablets distributed nationwide due to cGMP deviations related to temperature abuse during manufacturing.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection vials (NDC 55150-0170-30) distributed nationwide due to temperature abuse during manufacturing that may affect product quality. No illnesses have been reported.
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