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 |
|---|---|---|---|---|
| Aug 9, 2023 | Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bot... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged ... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manuf... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and pota... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% ... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 2, 2023 | Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-0... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Aug 2, 2023 | Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 307... | CGMP Deviations | Class II | Parker Laboratories, Inc. |
| Jul 21, 2023 | Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distri... | cGMP deviations: Batch was released prior to approval. | Class II | Aurobindo Pharma USA Inc. |
| Jul 21, 2023 | Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules pe... | CGMP deviation: product released prior to supplier approval. | Class II | The Ritedose Corporation |
| Jul 21, 2023 | Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... | cGMP deviations: Batch was released prior to approval. | Class II | Aurobindo Pharma USA Inc. |
| Jul 20, 2023 | FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... | cGMP deviations: due to shipment of rejected units. | Class II | SCA Pharmaceuticals |
| Jul 10, 2023 | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60... | CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... | Class II | New England Life Care, Inc. dba Advanced Compou... |
| Jul 10, 2023 | Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic... | CGMP Deviation: impurities exceed allowable limits. | Class II | Tenn South Distillery LLC dba Big Machine Disti... |
| Jul 10, 2023 | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, A... | CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... | Class II | New England Life Care, Inc. dba Advanced Compou... |
| Jul 10, 2023 | ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Com... | CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... | Class II | New England Life Care, Inc. dba Advanced Compou... |
| Jul 10, 2023 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515... | CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... | Class II | New England Life Care, Inc. dba Advanced Compou... |
| Jun 23, 2023 | Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), pac... | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Class II | Kramer Laboratories, Inc. |
| Jun 23, 2023 | Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppress... | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Class II | Kramer Laboratories, Inc. |
| Jun 13, 2023 | Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... | Class II | K.C. Pharmaceuticals, Inc |
| Jun 13, 2023 | Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... | Class II | K.C. Pharmaceuticals, Inc |
| Jun 12, 2023 | Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va... | cGMP deviations: potential for Microbial Contamination of Non-Sterile Products | Class II | Ferring Pharmaceuticals Inc |
| Jun 5, 2023 | Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufa... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| 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. |
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.