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.
Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.
Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.
Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects approximately 11.45 million tablets distributed in New York.
Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.
Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.
Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.
Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.
Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.
Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.
Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.
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