Browse Drug Recalls
1,392 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,392 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 1,392 FDA drug recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 24, 2022 | Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Ma... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD ... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by Z... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afas... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylep... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count pac... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffein... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (aceta... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorp... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium ... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 24, 2022 | Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... | cGMP deviations | Class II | Ultra Seal Corporation |
| Jan 21, 2022 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) top... | cGMP deficiencies | Class II | Mylan Pharmaceuticals Inc |
| Jan 19, 2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| 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 14, 2022 | Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only... | Failed Impurities/Degradation Specifications | Class II | Aurobindo Pharma USA Inc. |
| Jan 14, 2022 | Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY,... | CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. | Class II | Mayne Pharma Inc |
| Jan 12, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... | Failed Dissolution Specifications. | Class II | Ascend Laboratories, LLC |
| Jan 11, 2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, ... | Lack of Assurance of Sterility | Class II | Exela Pharma Sciences LLC |
| Jan 11, 2022 | Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The L... | cGMP deviations | Class II | Pharmasol Corporation |
| Jan 10, 2022 | Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)... | CGMP Deviations | Class II | Ingenus Pharmaceuticals 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 10, 2022 | Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... | Subpotent drug | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 7, 2022 | Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... | Failed Stability Specifications | Class II | VistaPharm, Inc. |
| Jan 5, 2022 | Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pe... | Labeling: Missing Label: label missing from some Semglee prefilled pens. | Class I | Mylan Pharmaceuticals Inc |
| Jan 5, 2022 | Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous an... | Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. | Class II | Akorn, 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. |
| 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 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... | 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 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... | 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 | Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... | 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 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... | Failed Dissolution Specifications | Class III | 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.