Browse Drug Recalls
1,020 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,020 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 1,020 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 9, 2018 | Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 5859... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 5859... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 585... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (ND... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, pa... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 5... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 5859... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a)... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (N... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone Cypionate USP (Micronized) for prescription compounding, packag... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 2... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-80... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 |
| Feb 5, 2018 | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... | Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Jan 29, 2018 | Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 29, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... | Subpotent Drug: Out of specification for assay (stability testing) | Class III | Mckesson Packaging Services |
| Jan 29, 2018 | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 29, 2018 | Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx ... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 24, 2018 | Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g... | Superpotent drug: failed assay throughout the stick after 6 months stability. | Class III | Oxygen Development Llc |
| Jan 16, 2018 | Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... | Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ... | Class III | Fresenius Kabi USA, LLC |
| 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. |
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.