Browse Drug Recalls

305 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 305 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 305 FDA drug recalls.

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DateProductReasonClassFirm
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
Apr 27, 2023 Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III 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 Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op... Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo... Class II 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
Feb 22, 2023 Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... Class II Teva Pharmaceuticals USA Inc
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
Jul 22, 2022 Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... Class III Teva Pharmaceuticals USA Inc
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Jun 29, 2022 Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... Superpotent Drug: Out of specification assay result was obtained during stability testing. Class II Teva Pharmaceuticals USA Inc
Jun 14, 2022 Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. 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
Apr 15, 2022 Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... cGMP Deviations Class II Teva Pharmaceuticals USA Inc
Mar 29, 2022 IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, ... Presence of Particulate Matter: Product was found to contain silica and iron oxide 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 Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactu... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
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

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.