Browse Drug Recalls
392 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 392 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 392 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 7, 2022 | Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. | Class II | Apotex Corp. |
| Jun 29, 2022 | Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant ... | Failed Dissolution Specifications | Class III | Eco Lips, Inc |
| Jun 29, 2022 | Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, H... | Failed Dissolution Specifications | Class III | Eco Lips, Inc |
| Jun 27, 2022 | Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 14, 2022 | Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... | Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 10, 2022 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... | Failed Dissolution Specifications: Out of specification test results observed in dissolution test... | Class II | Lupin Pharmaceuticals Inc. |
| May 11, 2022 | Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... | Class I | Teva Pharmaceuticals USA Inc |
| May 3, 2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... | Class III | Apotex Corp. |
| May 3, 2022 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... | Class III | American Health Packaging |
| Apr 28, 2022 | Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl... | Failed Dissolution Specifications: low out of specification results for dissolution. | Class II | Viatris Inc |
| Apr 28, 2022 | alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... | Failed Dissolution Specifications: low out-of-specification dissolution test results observed. | Class II | Viatris Inc |
| Apr 15, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 28, 2022 | Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delay... | Out of specification results observed in dissolution during long term stability testing. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2022 | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... | Failed Dissolution Specifications; during long term stability testing. | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 23, 2022 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... | Failed Dissolution Specifications; during long term stability testing. | Class II | Dr. Reddy's Laboratories, Inc. |
| Feb 28, 2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jan 18, 2022 | Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... | Failed Dissolution Specification: Dissolution results are below specification limits for the acti... | Class II | Teva Pharmaceuticals USA |
| Jan 12, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... | Failed Dissolution Specifications. | Class II | Ascend Laboratories, LLC |
| Jan 10, 2022 | Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... | Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. | Class II | Teva Pharmaceuticals USA |
| Jan 4, 2022 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 | QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Dec 20, 2021 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, R... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Dec 2, 2021 | Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 8, 2021 | Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo... | Out of specification result observed in a dissolution test at the 9-month long term stability tim... | Class II | Lupin Pharmaceuticals Inc. |
| Sep 27, 2021 | Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Sep 17, 2021 | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... | Failed Dissolution Specifications: results were above specification. | Class II | American Health Packaging |
| Aug 23, 2021 | Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx... | Failed Dissolution Specifications | Class II | Viatris |
| Aug 6, 2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jul 29, 2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, D... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jul 2, 2021 | NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... | Failed Dissolution Specification: Out of specification for dissolution during routine stability t... | Class II | The Harvard Drug Group |
| Apr 1, 2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... | Failed Dissolution Specifications | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 15, 2021 | NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAP... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Feb 26, 2021 | Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... | Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... | Class II | Dr. Reddy's Laboratories, Inc. |
| Feb 17, 2021 | Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-3... | Failed Dissolution Specifications | Class II | Dr. Reddy's Laboratories, 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.