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.
Carolina Infusion is recalling TRI-MIX 30/2/20 Injectable due to lack of assurance of sterility. Multiple lots were distributed nationwide to healthcare providers.
Vi-Jon, LLC voluntarily recalled Magnesium Citrate Saline Laxative due to manufacturing process deviations. Over 8 million units of the product were distributed nationwide.
Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed nationwide and internationally.
Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.
Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.
Plastikon Healthcare LLC has recalled Milk of Magnesia USP nationwide due to microbial contamination in non-sterile products. The affected lot (20071A) included approximately 24,400 institutional-use cups.
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to microbial contamination in non-sterile products. Lot 20074A, distributed nationwide for institutional use, should not be used.
Plastikon Healthcare LLC is recalling an antacid oral suspension distributed nationwide due to microbial contamination. Affected lots 20051A (exp. Aug. 2022) and 20088A (exp. Sep. 2022) should not be used.
Plastikon Healthcare LLC is recalling 220,500 cups of antacid containing magnesium hydroxide and aluminum hydroxide due to microbial contamination.
CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion nationwide due to defective protective caps that could expose the dropper tip and compromise sterility. No injuries have been reported.
Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.
Cipla is recalling 117,844 bottles of Difluprednate eye drops nationwide due to defective containers where the protective cap can break, potentially exposing the dropper tip and compromising sterility.
CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.
Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.
Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.
Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution due to manufacturing process control deviations. The product was distributed nationwide for institutional use only.
CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide due to manufacturing process control deviations that did not meet required quality standards.
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.
Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
Looking for a different category? Browse all recalls.