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.
Exela Pharma Sciences is recalling 38,200 vials of ELCYS (cysteine hydrochloride injection) nationwide due to the presence of silicone particulate matter.
Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.
LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.
Integrity Biochem HSC 70-LM hand sanitizer in 55-gallon drums (Lot #2133607, manufactured 11/23/2021) is being recalled due to acetal and acetaldehyde contamination above FDA standards. Product was distributed to an Oklahoma distributor.
ITF Pharma is recalling 1,792 bottles of Tiglutik (riluzole) oral suspension due to out-of-specification viscosity test results. The affected lots are 2231901 and 2307901, distributed to Tennessee.
Integrity Biochem hand sanitizer recalled due to contamination with acetal and acetaldehyde at levels above FDA standards. The product was distributed to one Oklahoma distributor.
Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.
FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.
Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.
NCS Healthcare recalled Lisinopril Tablets USP 20 mg nationwide due to potential presence of stray Amlodipine Besylate 10 mg tablets in certain lots. No illnesses have been reported.
Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.
Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.
Omega & Delta Co., Inc. is recalling specific lots of DOP Instant Hand Sanitizer because they do not meet established potency standards. Some batches are sub-potent or super-potent, potentially affecting antimicrobial effectiveness or causing irritation.
Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen distributed nationwide due to manufacturing practice deviations. Cylinders were manufactured between May 10 and October 31, 2023.
Pfizer is recalling 3,200 vials of Lidocaine Hydrochloride 2% Injection due to the presence of glass particulates. The injectable medication was distributed nationwide in the US and Puerto Rico.
Pfizer Inc. is recalling 4.2% Sodium Bicarbonate Injection (24,900 vials) nationwide due to the presence of glass particulate matter. This Class I recall affects an injectable medication used in healthcare settings.
Pfizer Inc. is recalling 21,390 vials of Lidocaine Hydrochloride 1% injection due to presence of glass particulate matter. Lot 42290DK with expiration 6/1/2024 is affected.
AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.
Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.
Zydus Pharmaceuticals is recalling Oxybutynin extended-release tablets due to failed dissolution testing. The tablets may not dissolve properly, potentially affecting drug efficacy.
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.
Dr. Reddy's Laboratories is recalling 1,656 bottles of Montelukast Sodium 10 mg tablets due to contamination with a foreign metoprolol tablet found in at least one bottle. Affected lots were distributed nationwide.
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