Browse Drug Recalls
114 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 114 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 114 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 |
| 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 |
| Apr 13, 2022 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG:... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| 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 |
| Sep 17, 2021 | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... | Failed Dissolution Specifications: results were above specification. | Class II | American Health Packaging |
| 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 | Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx onl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inh... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| 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 |
| Jun 2, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 620... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Teva Pharmaceuticals USA |
| Jun 2, 2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | 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. |
| Sep 6, 2019 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 coun... | GMP Deviation: lot not intended for commercial distribution. | Class III | Teva Pharmaceuticals USA |
| 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 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, U... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bo... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, U... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | 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 |
| Apr 23, 2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Jan 29, 2018 | Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (ND... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | 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.