Browse Drug Recalls
3,368 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,368 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 3,368 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| 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 | 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 | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lup... | 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 | 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 | 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 | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| 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 | Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc... | 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 | Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... | 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 | 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 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| 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 | Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... | 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 | Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAta... | 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 | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... | 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 | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactu... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx onl... | 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 | 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 | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 | Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Man... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labo... | 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 | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| 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 | CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... | 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 | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... | CGMP Deviations | Class II | ULTRAtab Laboratories, Inc. |
| 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 | 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 | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... | 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.