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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
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 Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
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 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
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, 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 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, 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
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 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 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 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 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 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 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 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 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 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 25, 2018 Atropine 0.01% Opth Solution, 5 mL droptainer, 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 PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) I... 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 Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier'... 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 DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 ... 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 Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, ... 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 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
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 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 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 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 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 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 PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, ... 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 Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1... 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 P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/... 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 P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 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 Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 24, 2018 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium S... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact... Failed Dissolution Specifications: Class II West-Ward Columbus Inc
Jul 24, 2018 Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac... Failed Dissolution Specifications: Class II West-Ward Columbus Inc
Jul 24, 2018 Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bot... Defective Container: Tamper Evident foil seal not completely intact. Class II Morton Grove Pharmaceuticals, Inc.
Jul 20, 2018 Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsid... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 We... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Climate Adaptation Cold & Damp, 2 fl.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl. oz. (59 mL),... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx No Sweat/Anti-Perspirant, 2 fl. oz. (59 mL), King Bio,... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic For... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 West... Microbial contamination Class I King Bio 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.