Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 26, 2026 | Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manuf... | Subpotent Drug | Class II | MACLEODS PHARMA USA, INC |
| Feb 26, 2026 | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Vall... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 24, 2026 | Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs... | Failed Dissolution Specifications | Class II | MYLAN PHARMACEUTICALS INC |
| Feb 19, 2026 | Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 e... | Failed Tablet/Capsule Specifications | Class III | Radnostix |
| Feb 18, 2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 18, 2026 | MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal S... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
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.