Browse Drug Recalls
151 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 151 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 151 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 |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets b... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, R... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (ND... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (ND... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Nov 7, 2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... | Defective Container - A defect in the side-seal which allows leakage of product. | Class III | Teva Pharmaceuticals USA, Inc |
| Oct 13, 2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg... | Subpotent drug; Clavulanate Potassium component | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| Oct 7, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHA... | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po... | Class II | Teva Pharmaceuticals USA, Inc |
| May 23, 2025 | Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in... | Presence of foreign tablets/capsules. | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 10, 2025 | Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... | Failed Stability Specifications - 12-month stability test result for one of the known peptides is... | Class II | Teva Pharmaceuticals USA, Inc |
| Aug 8, 2024 | Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Te... | Superpotent Drug | Class II | Teva Pharmaceuticals USA, Inc |
| Jul 2, 2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorba... | Defective container: potential for non-sealed pouches which can lead to product leakage. | Class III | Novel Laboratories, Inc. d.b.a Lupin Somerset |
| Jun 28, 2024 | Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, ... | Failed Impurities/Degradation Specifications: Product is being recalled due to API related substa... | Class II | Teva Pharmaceuticals USA, Inc |
| Jun 4, 2024 | Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-co... | Subpotent Drug | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 28, 2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 7, 2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 8, 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Nov 10, 2023 | Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose pack... | OOS for viscosity | Class III | Teva Pharmaceuticals USA, Inc |
| Jul 5, 2023 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured B... | Failed Moisture Limits: Water (moisture) content above the approved product specifications. | Class II | Teva Pharmaceuticals USA Inc |
| Mar 27, 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Class III | Teva Pharmaceuticals USA Inc |
| Feb 23, 2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ... | Packaging defect: observed packaging defect, blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| Aug 29, 2022 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually... | Class II | Teva Pharmaceuticals USA Inc |
| Aug 23, 2022 | Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute... | CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing... | Class II | Teva Pharmaceuticals USA Inc |
| May 18, 2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class III | Teva Pharmaceuticals USA Inc |
| May 11, 2022 | Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... | Class I | Teva Pharmaceuticals USA Inc |
| Feb 4, 2022 | PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton togethe... | Non-sterility | Class I | CooperSurgical, Inc |
| Jan 26, 2022 | AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 10, 2022 | Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... | Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. | Class II | Teva Pharmaceuticals USA |
| Dec 31, 2021 | Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Dec 31, 2021 | MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Dec 16, 2021 | Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) ... | Subpotent | Class II | Teva Pharmaceuticals USA |
| Dec 8, 2021 | Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottl... | Defective Container: The notch in the cap that fits into the nozzle of the dropper could break of... | Class II | Teva Pharmaceuticals USA |
| Oct 27, 2021 | Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx... | Labelling: Incorrect Exp. Date | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vi... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Ph... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jun 18, 2021 | Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... | Class I | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
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.