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.
Daytrana (methylphenidate) patches are being recalled due to ripping patches and poor adhesive transfer affecting drug delivery. This Class II recall involves 8,559 cartons distributed nationwide.
PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.
PD-Rx Pharmaceuticals recalls Losartan Potassium Tablets (25 mg, 90-tablet bottles) due to Current Good Manufacturing Practice deviations. Specific lot numbers contain AZIDO impurity levels above acceptable limits.
Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.
Akorn, Inc. is recalling Calcipotriene Topical Solution 0.005% (Scalp Solution) nationwide due to a defective delivery system that could prevent the product from dispensing properly.
Mohnark Pharmaceuticals is recalling Lidocaine 4% Topical Anesthetic Cream because the packaging does not meet child-resistant requirements, creating a poisoning risk if young children ingest the product. About 9,000 units sold online were affected.
Sun Pharmaceutical recalls 97,450 vials of Testosterone Cypionate Injection nationwide due to manufacturing deviations that could cause out-of-specification impurities.
Sun Pharmaceutical is recalling approximately 47,500 vials of Testosterone Cypionate Injection due to a manufacturing deviation that may have affected product sterility.
Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets (0.125mg) due to manufacturing defects where oversized tablets were found. The affected lot (MHC1430A, exp. 09/2023) was distributed nationwide.
Teva Pharmaceuticals is recalling Tretinoin Capsules (10 mg) nationwide due to failed dissolution specifications that may affect medication effectiveness. Patients should contact their pharmacist or doctor to confirm if their prescription is affected.
Vi-Jon's 70% isopropyl alcohol bottles may leak when squeezed or tilted due to defects in the bottle neck finish. Over 3 million bottles with various lot numbers were distributed nationwide.
EarthLab Inc is recalling Wise Woman Herbals Sleepytime Glycerite due to elevated yeast and mold levels detected in microbial testing. Consumers should discontinue use.
Mayne Pharma is recalling 1,440 cartons of Clonidine transdermal patches nationwide due to an out-of-specification defect in the release liner that could affect proper drug delivery.
Artri King Reforzado con Ortiga Omega 3 Tablets are being recalled for containing undeclared diclofenac and being marketed without FDA approval. The recall affects 1,308 bottles distributed nationwide.
A.P. Nonweiler is recalling its 80% alcohol antiseptic hand sanitizer because FDA testing found acetaldehyde and acetal above safe specification limits. The product was distributed in Wisconsin and Virginia.
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension due to lack of assurance of sterility. The recall affects approximately 57,997 prefilled syringes distributed nationwide.
Sun Pharmaceutical is recalling 26,892 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL) distributed nationwide due to lack of assurance of sterility. The affected lots expire between January and June 2023.
Washington Homeopathic Products recalled Bacillinum Pulmo homeopathic drug due to manufacturing practice deviations. The Class II recall, initiated in May 2022 and terminated in May 2023, affected nationwide distribution.
Hand Sanitizer LLC is recalling Say Goodbye to Germs hand sanitizer bottles due to CGMP deviations. FDA testing found acetaldehyde and acetal levels above acceptable limits.
Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.
Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.
Washington Homeopathic Products is recalling Proteus homeopathic remedy in multiple potencies due to manufacturing process deviations. The firm initiated this voluntary recall in May 2022.
Sun Pharmaceutical is recalling 4,625 syringes of Medroxyprogesterone Acetate Injectable Suspension (Lot HAC1951A) due to lack of assurance of sterility. The affected medication was distributed nationwide.
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) nationwide due to lack of assurance of sterility. Affected lots contain vials with expiration dates from December 2022 through September 2023.
Washington Homeopathic Products is recalling Anthracinum liquid pellets due to manufacturing process deviations. The voluntary recall affects 219 bottles distributed nationwide.
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