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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.

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DateProductReasonClassFirm
Jun 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaL... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Ge... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distr... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: Ste... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distribute... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distr... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distribu... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New Y... cGMP deviations Class II Homeocare Laboratories, Inc.
May 25, 2023 Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II Viatris Inc
May 16, 2023 FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Alpha Aromatics
May 9, 2023 HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
May 3, 2023 Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaife... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottl... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Do... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactur... CGMP Deviations Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 3, 2023 Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL ... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 1, 2023 LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II RemedyRepack Inc.
May 1, 2023 Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II RemedyRepack Inc.
May 1, 2023 Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II RemedyRepack Inc.
Apr 26, 2023 Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, ... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx O... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intraveno... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous U... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manuf... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured b... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Dis... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, D... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn O... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distribute... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operatin... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL amp... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distrib... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, R... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Di... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distr... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx ... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manu... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL S... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, 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.