Browse Drug Recalls
1,045 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,045 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 1,045 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 3, 2018 | Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... | Failed Dissolution Specifications: Low out of specification results for dissolution during annual... | Class II | AVKARE Inc. |
| Dec 20, 2017 | Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. ... | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Class II | Odan Laboratories Ltd |
| Dec 20, 2017 | Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxyben... | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Class II | Odan Laboratories Ltd |
| 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 |
| Dec 14, 2017 | SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... | Failed Stability Specifications | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Dec 13, 2017 | INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... | Failed Stability Specifications: Product stability testing results did not meet specifications fo... | Class II | ALLERGAN |
| Dec 4, 2017 | Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, ... | Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did ... | Class II | ALLERGAN |
| Nov 10, 2017 | Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spa... | Failed Stability Specifications | Class III | Bayer HealthCare 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. |
| Oct 3, 2017 | Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV... | Failed impurities/degradation specifications: Famotodine has an out of specification result for a... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 2, 2017 | Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was o... | Class II | Unichem Pharmaceuticals Usa Inc |
| Sep 13, 2017 | Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distribute... | Failed Stability Specifications | Class III | Vi-Jon, Inc. |
| Sep 5, 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... | Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... | Class III | Aidarex Pharmaceuticals LLC |
| Aug 29, 2017 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... | Failed Stability Specifications | Class III | Amerisource Health Services |
| Aug 10, 2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... | Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... | Class II | Premier Pharmacy Labs Inc |
| Aug 3, 2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... | Class III | KVK-Tech, Inc. |
| 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 20, 2017 | Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for... | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/... | Class II | Hetero USA Inc |
| Jun 22, 2017 | Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... | Class III | Lupin Pharmaceuticals Inc. |
| Jun 9, 2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| 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 |
| May 24, 2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri... | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Class III | Shionogi Inc. |
| May 24, 2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b... | Presence of foreign substance: The recall was initiated due to black particles being observed whi... | Class III | Shionogi Inc. |
| May 24, 2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Class III | Shionogi Inc. |
| May 9, 2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... | Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... | Class III | Strides Pharma INC |
| May 1, 2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... | Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... | Class II | Allergan Sales, LLC |
| Apr 27, 2017 | Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... | Defective Delivery System: Out of specification for peel force from the release liner specificati... | Class III | Noven Pharmaceuticals, Inc. |
| Mar 28, 2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... | Failed Stability Specifications | Class III | Teva Pharmaceuticals USA |
| Mar 28, 2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... | Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 15, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... | Failed Dissolution Specifications; 9 month long term stability | Class II | Zydus Pharmaceuticals USA Inc |
| Feb 17, 2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications: low out of specification dissolution results found during stab... | Class III | Teva Pharmaceuticals USA |
| Feb 7, 2017 | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and ... | Class II | G & W Laboratories, Inc. |
| Feb 7, 2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... | Class III | Actavis Inc |
| Jan 13, 2017 | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... | Failed Stability Specifications: confirmed out of specification results obtained during refrigera... | Class II | AbbVie Inc. |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| Dec 28, 2016 | Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 28, 2016 | Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 28, 2016 | Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 28, 2016 | Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R... | Failed Dissolution Specifications; 18 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 22, 2016 | TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:... | Failed Stability Specifications | Class III | Vintage Pharmaceuticals LLC, DBA Qualitest Phar... |
| Dec 21, 2016 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... | Subpotency: due to a low, out of specification test result for assay during stability testing. | Class II | Teva Pharmaceuticals USA |
| Dec 20, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... | Failed Dissolution Specifications; 18 month stability time point | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 20, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... | Failed Dissolution Specifications; 18 month stability time point | Class III | Sun Pharmaceutical Industries, Inc. |
| Dec 6, 2016 | INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only,... | Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed vari... | Class III | Cipher Pharmaceuticals US LLC |
| Nov 22, 2016 | PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... | Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. | Class III | Pfizer Inc. |
| Nov 17, 2016 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5... | Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 14, 2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... | Failed Stability Specifications; out-of specification value for homogeneity / phase separation. | Class II | Akorn 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.