Browse Drug Recalls
39 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 39 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 39 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 8, 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Apr 20, 2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... | Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... | Class III | Bryant Ranch Prepack, Inc. |
| 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 |
| 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 |
| Jan 18, 2022 | Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... | Failed Dissolution Specification: Dissolution results are below specification limits for the acti... | Class II | Teva Pharmaceuticals USA |
| Oct 28, 2021 | Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... | Failed Impurities/Degradation Specifications | Class III | 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 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... | Class II | Teva Pharmaceuticals USA |
| Mar 15, 2021 | Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-406... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Nov 11, 2020 | Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose ... | Superpotent Drug: High out-of-specification assay results were obtained during stability testing. | Class III | Teva Pharmaceuticals USA |
| Oct 28, 2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ... | Class II | Teva Pharmaceuticals USA |
| Jul 14, 2020 | Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not ... | Class II | Teva Pharmaceuticals USA |
| Feb 20, 2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... | Failed Dissolution Specifications: Low out of specification dissolution result observed during st... | Class II | Teva Pharmaceuticals USA |
| Jan 27, 2020 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 27, 2020 | Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Nov 4, 2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... | Presence of foreign substance: Brown/black particles found during stability testing. | Class II | Teva Pharmaceuticals USA, Inc. |
| Oct 19, 2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R... | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, ... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(ND... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, R... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Aug 6, 2018 | Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(ND... | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling... | Class II | Teva Pharmaceuticals USA |
| Jul 5, 2018 | Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, ... | Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) t... | Class II | Teva Pharmaceuticals USA |
| Oct 25, 2017 | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... | Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... | Class II | Teva Pharmaceuticals USA |
| May 31, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... | Class I | Teva Pharmaceuticals |
| Aug 30, 2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... | Class III | Actavis Laboratories, FL, Inc. |
| Sep 25, 2015 | Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. | Class II | Actavis Laboratories, FL, Inc. |
| Jun 23, 2015 | Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured... | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | Class III | Actavis Laboratories, FL, Inc. |
| Apr 14, 2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis... | Subpotent Drug: Flurandrenolide is subpotent. | Class III | Actavis Laboratories |
| Mar 26, 2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... | Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... | Class III | Actavis Laboratories, FL, Inc. |
| Sep 26, 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Presence of split or broken tablets. | Class II | Actavis Laboratories, FL, Inc. |
| Apr 24, 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Class II | Actavis Laboratories, FL, Inc. |
| Apr 24, 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Class II | Actavis Laboratories, FL, 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.