Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 4, 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w... | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... | Class II | Professional Disposables International, Inc. |
| Feb 4, 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.... | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... | Class II | Professional Disposables International, Inc. |
| Jan 26, 2022 | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufa... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered In... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby La... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuati... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Heal... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healt... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsul... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per carton... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, I... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tab... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufact... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: A... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Conta... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured b... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTR... | CGMP Deviations | Class II | ULTRAtab 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.