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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 DEPO-MEDROL (methylprednisolone acetate) injectable suspension nationwide due to temperature abuse during manufacturing that may have affected product quality. No illnesses have been reported.
McKesson Medical-Surgical is recalling Bupivacaine Hydrochloride Injection due to temperature abuse during storage that may have compromised product sterility. The recall affects 224 cartons distributed nationwide.
Mckesson Medical-Surgical is recalling Levofloxacin 500 mg tablets nationwide due to temperature abuse during manufacturing that violated pharmaceutical quality standards.
McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide because of temperature control failures during manufacturing that violate cGMP standards.
McKesson Medical-Surgical is recalling Labetalol Hydrochloride Tablets 100 mg due to temperature abuse during manufacturing that may affect drug stability. This Class II recall affects units distributed nationwide.
McKesson is recalling Revonto (dantrolene sodium injection) due to temperature abuse during storage and distribution affecting 16 cartons distributed nationwide.
Epinephrine auto-injectors distributed nationwide are being recalled due to temperature abuse during manufacturing. Temperature exposure may degrade the medication and reduce its emergency effectiveness.
EAR CARE EARACHE DROPS are being recalled nationwide due to potential microbial contamination. Rite Aid is recalling 16,374 bottles of the homeopathic otic product.
McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to cGMP deviations involving temperature abuse during manufacturing. Affected vials were distributed nationwide.
US Specialty Formulations is recalling 781 vials of Ethanol for Injection 95% due to lack of assurance of sterility. The product was distributed nationwide to medical facilities and physician offices.
McKesson Medical-Surgical is recalling Methylprednisolone Acetate Injectable Suspension nationwide due to temperature control violations in manufacturing. The affected product was distributed to healthcare providers across the United States.
MethyLPREDNISolone Acetate Injectable Suspension (400 mg/10 mL) is recalled due to temperature abuse during storage that may have compromised product quality. Approximately 796 vials were distributed nationwide.
McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Aerosol HFA due to temperature exposure during manufacturing that caused deviations from manufacturing practice standards. The affected product was distributed nationwide.
US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.
McKesson is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.
McKesson Medical-Surgical is recalling Sodium Bicarbonate Antacid Tablets nationwide due to temperature abuse during manufacturing. Consumers should consult their healthcare provider about continued use.
McKesson Medical-Surgical is recalling Gastrografin, a prescription diagnostic contrast agent, due to temperature abuse during manufacturing and distribution. The FDA classified this as a Class II recall.
Mckesson Medical-Surgical is recalling Meclizine Hydrochloride 25mg tablets nationwide due to manufacturing deviations involving improper temperature control. The FDA classified this as a Class II recall.
McKesson Medical-Surgical is recalling Promethazine HCl Tablets, 25 mg, due to temperature deviations during manufacturing that did not comply with current good manufacturing practices. The recall affects 16 cartons distributed nationwide.
McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.
Mckesson Medical-Surgical is recalling MethyLPREDNISolone Acetate Injectable Suspension due to temperature-abuse cGMP deviations affecting 363 vials distributed nationwide.
McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride injections distributed nationwide due to manufacturing deviations involving temperature abuse that may have compromised the drug's potency and sterility.
Prednisolone Acetate ophthalmic suspension is being recalled nationwide due to temperature deviations during distribution. McKesson Medical-Surgical has notified affected customers.
McKesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.
McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.
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