Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2026 | Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection US... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 20, 2026 | Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP... | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Class II | Fagron Compounding Services |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manu... | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f... | Class II | Amneal Pharmaceuticals, LLC |
| Mar 17, 2026 | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL S... | Labelling: Illegible label | Class II | Nephron SC, LLC |
| Mar 17, 2026 | Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx ... | Failed Dissolution Specifications | Class II | Viatris, Inc. |
| Mar 17, 2026 | CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... | Lack of Assurance of Sterility | Class II | Chiesi USA, Inc. |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Mar 16, 2026 | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60... | Failed tablet specifications. | Class II | Amerisource Health Services LLC |
| Mar 13, 2026 | Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, R... | Presence of particulate matter: identified as Buprenorphine free base | Class II | ENDO USA, Inc. |
| Mar 13, 2026 | Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1... | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for ... | Class II | Cipla USA, Inc. |
| Mar 13, 2026 | Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Singl... | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for ... | Class II | Cipla USA, Inc. |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL i... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL f... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 m... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL f... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL i... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 1... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL),... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 11, 2026 | 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 ... | Lack of Assurance of Sterility | Class II | Fresenius Kabi USA, LLC |
| Mar 9, 2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Mar 6, 2026 | Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL ... | Lack of Assurance of Sterility | Class II | PAYLESS COMPOUNDERS, LLC |
| Mar 5, 2026 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| Mar 3, 2026 | HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) ... | Chemical contamination: Presence of benzene | Class II | Owen Biosciences Inc. |
| Mar 3, 2026 | SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 ... | Chemical contamination: Presence of benzene | Class II | Owen Biosciences Inc. |
| Mar 3, 2026 | SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles... | Chemical contamination: Presence of benzene | Class II | Owen Biosciences Inc. |
| Mar 3, 2026 | FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE A... | Chemical contamination: Presence of benzene | Class II | Owen Biosciences Inc. |
| Mar 3, 2026 | STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene ... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and t... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene ... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (1... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), S... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc |
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Mar 2, 2026 | Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) b... | Presence of foreign substance: the firm received complaints for a gel-like mass and black particl... | Class II | STRIDES PHARMA INC |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.