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 7, 2021 | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Dec 18, 2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i... | Class III | KVK-Tech, Inc. |
| Nov 20, 2020 | Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic... | Subpotency: Out-of-specification stability test result for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Nov 11, 2020 | Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, ... | Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5... | Class III | InvaTech Pharma Solutions, LLC |
| 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 |
| Oct 23, 2020 | Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis... | Failed impurities/ degradation specifications: Out of specification impurity results were observe... | Class III | Heritage Pharmaceuticals Inc |
| Oct 2, 2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac... | Out-of-specification organic impurity results obtained during routine stability testing. | Class III | Mylan Pharmaceuticals Inc. |
| Sep 16, 2020 | Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc.... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 9, 2020 | Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... | Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9... | Class III | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Sep 4, 2020 | Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal... | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Class II | Teva Pharmaceuticals USA |
| Aug 14, 2020 | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Class II | Hikma Pharmaceuticals USA Inc. |
| Aug 10, 2020 | Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... | Failed Stability Specifications: Out of Specification result for enzyme activity levels noted dur... | Class II | Sanofi-Aventis U.S. LLC |
| Aug 3, 2020 | Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... | Class III | Ultra Seal Corporation |
| Aug 3, 2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... | Class III | Ultra Seal Corporation |
| Jul 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| Jul 6, 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... | Cross contamination with other products - OOS discovered during routine stability testing for hig... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 29, 2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... | Class II | RemedyRepack Inc. |
| Jun 16, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| May 14, 2020 | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... | Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... | Class III | InvaGen Pharmaceuticals, Inc. |
| May 5, 2020 | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... | Discoloration: Out-of-specification results for appearance obtained during routine stability test... | Class II | Mylan Institutional LLC |
| Apr 24, 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... | Class III | The Harvard Drug Group |
| Apr 18, 2020 | Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... | Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... | Class I | B. Braun Medical Inc |
| Apr 15, 2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... | Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. | Class II | Lupin Pharmaceuticals Inc. |
| Mar 19, 2020 | DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... | Failed Stability Specifications | Class II | Jubilant Draximage Inc |
| Feb 24, 2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... | Class III | Breckenridge Pharmaceutical, Inc |
| 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 |
| Feb 12, 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... | Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 13, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | The Harvard Drug Group |
| Dec 10, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 4, 2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... | Failed Dissolution Specifications: Low out of specification results obtained during stability tes... | Class II | American Health Packaging |
| 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. |
| Oct 30, 2019 | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceu... | Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron con... | Class II | Avantor Performance Materials Inc |
| Sep 6, 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... | Class II | Torrent Pharma Inc. |
| Aug 28, 2019 | AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... | Failed Stability Specifications. | Class II | AVKARE Inc. |
| Aug 21, 2019 | Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... | Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... | Class III | Macleods Pharma Usa Inc |
| Jul 17, 2019 | Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... | Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 11, 2019 | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspe... | Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the a... | Class II | Tris Pharma Inc. |
| Jul 9, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... | Failed dissolution specifications : failed results at the 3-month stability time point. | Class I | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 2, 2019 | Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025... | Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification resu... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 21, 2019 | ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural 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.