Browse Drug Recalls

1,110 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,110 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 1,110 FDA drug recalls in CA.

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DateProductReasonClassFirm
Jan 25, 2019 the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pru... Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... Class I Natures Rx
Jan 10, 2019 Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 m... Presence of Particulate Matter: filmy/cloudy particulate observed in vial. Class II McGuff Compounding Pharmacy Services, Inc.
Dec 11, 2018 Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 11, 2018 Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Nov 5, 2018 puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... Non-Sterility: Product manufactured under non-sterile production conditions. Class I Kadesh International
Nov 2, 2018 IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 2, 2018 IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 2, 2018 IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Oct 18, 2018 GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg... Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 mont... Class II H J Harkins Company Inc dba Pharma Pac
Oct 5, 2018 Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90... Container packaging defect. Class III Orexigen Therapeutics, Inc.
Aug 30, 2018 Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum,... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Alkano Chemicals, Inc
Aug 23, 2018 Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a phy... Class II Pacific Compounding Pharmacy & Consultations Inc
Aug 21, 2018 Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central D... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Cent... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multi... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 15, 2018 Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx On... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Preferred Pharmaceuticals, Inc
Aug 9, 2018 Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90... Defective Container: Customer complaints of punctures in the bottle. Class III Orexigen Therapeutics, 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 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 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
Jun 27, 2018 Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 25, 2018 Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 25, 2018 Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 25, 2018 Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Wate... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 11, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II BioDiagnostic International
May 25, 2018 Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
Apr 24, 2018 Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct f... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannet... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laborat... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 12, 2018 Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadal... Class I AMA Wholesale

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.