Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2018 | Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g)... | Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological g... | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chlo... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as ... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL O... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relie... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (1... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Ch... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl O... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15... | Superpotent Drug: high out of specification assay results for the menthol ingredient. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Dis... | Subpotent drug: The product active ingredient level not matching the exact levels indicated on th... | Class III | Huijing (Shanghai) Bio-tech Co., Ltd. |
| Aug 3, 2018 | CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. ... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%... | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcu... | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 F... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer La... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 2, 2018 | Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandal... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale B... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Halla... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale ... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale B... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R... | Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot... | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Aug 1, 2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... | Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... | Class II | Akorn, Inc. |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Aug 1, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... | Failed Dissolution Specifications: Out of specification result for the dissolution test. | Class II | American Health Packaging |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Jul 30, 2018 | Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Ph... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | NuCare Pharmaceuticals Inc |
| Jul 30, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do... | Failed Dissolution Specifications | Class II | MAJOR PHARMACEUTICALS |
| Jul 30, 2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | NuCare Pharmaceuticals Inc |
| Jul 30, 2018 | Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Ph... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | NuCare Pharmaceuticals Inc |
| Jul 27, 2018 | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bott... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Bryant Ranch Prepack Inc. |
| Jul 27, 2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottle... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Bryant Ranch Prepack Inc. |
| Jul 27, 2018 | Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Pack... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Bryant Ranch Prepack Inc. |
| Jul 26, 2018 | Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grape... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label | Class III | Right Value Drug Stores, Inc. |
| Jul 26, 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 26, 2018 | Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkin... | Carcinogen impurity detected in API used to manufacture drug product. | Class II | H J Harkins Company Inc dba Pharma Pac |
| Jul 25, 2018 | Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Labor... | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... | Class II | Ranier's Compounding Laboratory |
| Jul 25, 2018 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Presence of foreign substance: Potential for glass in the neck area of the glass bottles. | Class II | Mylan Pharmaceuticals Inc. |
| Jul 25, 2018 | Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 m... | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... | Class II | Ranier's Compounding Laboratory |
| Jul 25, 2018 | Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laborator... | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... | Class II | Ranier's Compounding Laboratory |
| Jul 25, 2018 | PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, ... | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... | Class II | Ranier's Compounding Laboratory |
| Jul 25, 2018 | alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g ... | Microbial Contamination of a Non-Sterile Product | Class II | The Hain Celestial Group, Inc. - Worldwide HQ |
| Jul 25, 2018 | Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laborat... | Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... | Class II | Ranier's Compounding Laboratory |
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.