Browse Drug Recalls
310 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 310 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 310 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | 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 |
| Sep 27, 2018 | Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class II | Teva Pharmaceuticals USA |
| Sep 21, 2018 | Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... | Class II | Teva Pharmaceuticals USA |
| Sep 20, 2018 | Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... | Failed Stability Specifications: Out-of-specification test result for water content obtained duri... | 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 | PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Taked... | 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 | Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Ma... | API material used in the manufacturing of the product did not receive regulatory approval prior t... | 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 30, 2018 | Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... | Failed Stability Specifications | Class III | Teva Pharmaceuticals USA |
| Mar 19, 2018 | Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0... | Defective Container: This recall is being initiated due to product complaints regarding difficult... | Class II | Teva Pharmaceuticals USA |
| Feb 5, 2018 | Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... | Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... | Class III | Teva Pharmaceuticals USA |
| 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 |
| Jan 29, 2018 | Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Fentanyl Transdermal System. 25 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 |
| Dec 14, 2017 | Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg,... | Failed Impurities/Degradation Specifications: High out of specification test result for the Moexi... | Class II | Teva Pharmaceuticals USA |
| Nov 28, 2017 | Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 1... | Failed Impurities/Degradation Specifications: high out of specification test results obtained for... | Class III | Teva Pharmaceuticals USA |
| Nov 20, 2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... | Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... | Class II | Teva Pharmaceuticals USA |
| Nov 9, 2017 | Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Is... | Failed Tablet/Capsule Specifications; potential presence of broken tablets. | 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 |
| Oct 17, 2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... | Failed Dissolution Specifications: Low out of specification results for dissolution. | Class III | Teva Pharmaceuticals USA |
| Sep 5, 2017 | Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... | Class II | Teva Pharmaceuticals USA |
| Aug 2, 2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 3... | Failed Moisture Limits: out of specification test results for water content obtained during stabi... | Class III | Teva Pharmaceuticals USA |
| Jul 25, 2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 po... | Failed Impurities/Degradation Specifications: high out of specification results for related compo... | Class III | Teva Pharmaceuticals USA |
| Jul 24, 2017 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For:... | Failed Tablet/Capsule Specification; out of specification for tablet weight | Class II | Teva Pharmaceuticals USA |
| Jun 29, 2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle... | Failed Impurities/Degradation Specifications: out of specification test results for related comp... | Class III | Teva Pharmaceuticals USA |
| Jun 29, 2017 | Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bot... | Failed Impurities/Degradation Specifications: out of specification test results for related comp... | Class III | 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 |
| Apr 24, 2017 | Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count... | Microbial Contamination of Non-Sterile Products | 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.