Browse Drug Recalls
120 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 120 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 120 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 20, 2018 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manuf... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Aug 27, 2018 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3... | Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. | Class III | Mylan Pharmaceuticals Inc. |
| Aug 14, 2018 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... | Failed Impurities/Degradation Specifications; out of specification results for related compound p... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Jul 25, 2018 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Presence of foreign substance: Potential for glass in the neck area of the glass bottles. | Class II | Mylan Pharmaceuticals Inc. |
| Jul 9, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bot... | Subpotent Drug | Class III | Mylan Pharmaceuticals Inc. |
| Jun 7, 2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... | Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... | Class III | Mylan Pharmaceuticals Inc. |
| May 1, 2018 | Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| May 1, 2018 | Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Apr 30, 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only,... | CGMP Deviations | Class II | Mylan Pharmaceuticals Inc. |
| Apr 30, 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 4... | CGMP Deviations | Class II | Mylan Pharmaceuticals Inc. |
| Apr 30, 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, ... | CGMP Deviations | Class II | Mylan Pharmaceuticals Inc. |
| Apr 24, 2018 | Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 | CGMP Deviations | Class II | Mylan Pharmaceuticals Inc. |
| Apr 24, 2018 | Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 | CGMP Deviations | Class II | Mylan Pharmaceuticals Inc. |
| Apr 24, 2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, M... | cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not... | Class II | Mylan Pharmaceuticals Inc. |
| Apr 24, 2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, M... | cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was n... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 3, 2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, R... | Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntar... | Class III | Mylan Pharmaceuticals Inc. |
| May 9, 2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals ... | Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurit... | Class III | Mylan Pharmaceuticals Inc. |
| Mar 21, 2017 | Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 30, 2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and ... | Chemical Contamination: out of specification results for impurities were found to be the result o... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 30, 2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 bli... | Chemical Contamination: out of specification results for impurities were found to be the result o... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 19, 2017 | glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan ... | Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 19, 2017 | Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bo... | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle | Class II | Mylan Pharmaceuticals Inc. |
| Nov 3, 2016 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 03... | Failed Impurities/Degradation Specifications: OOS results for known compound. | Class III | Mylan Pharmaceuticals Inc. |
| Jun 22, 2016 | Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Ma... | Failed Dissolution Specifications | Class II | Mylan Pharmaceuticals Inc. |
| Feb 12, 2016 | Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Myl... | Failed Dissolution Specifications; three month stability time point. | Class II | Mylan Pharmaceuticals Inc. |
| Jan 28, 2016 | Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by M... | Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jun 30, 2015 | Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceu... | Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were ob... | Class II | Mylan Pharmaceuticals Inc |
| Mar 26, 2015 | Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... | Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 11, 2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outd... | Failed Impurities/Degradation Specifications: out of specification results for a related compound... | Class III | Mylan Pharmaceuticals Inc. |
| Jul 3, 2014 | Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, R... | Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and ... | Class II | Mylan Pharmaceuticals Inc. |
| Jul 3, 2014 | Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... | Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jun 20, 2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharma... | Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. | Class III | Mylan Pharmaceuticals Inc. |
| Jun 19, 2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 14, 2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distri... | Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets,... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 26, 2013 | LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 bl... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 26, 2013 | CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card.... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 17, 2013 | Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) ... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 17, 2013 | Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) ... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 17, 2013 | Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) u... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bott... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals 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.