Browse Drug Recalls

1,076 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,076 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 1,076 FDA drug recalls in CA.

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DateProductReasonClassFirm
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
Apr 10, 2018 Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 Presence of Foreign Tablets/Capsules Class III Aidarex Pharmaceuticals LLC
Apr 2, 2018 ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Apr 2, 2018 WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dis... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Mar 30, 2018 PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... Microbial Contamination of Non-Sterile Products Class II Marcas Usa Llc
Mar 29, 2018 Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC ... CGMP Deviations: the product was produced with substandard GMP manufacturing processes. Class II United Pacific Co Ltd
Mar 8, 2018 Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pa... Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tada... Class I Jimmy Weber
Feb 16, 2018 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PI... Presence of Particulate Matter: Customer complaint of particulate matter which has been identifie... Class II B. Braun Medical Inc
Feb 14, 2018 Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural ... Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence... Class I Bella All Natural
Feb 5, 2018 Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... Class III Genentech, Inc.
Dec 28, 2017 Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe a... Microbial Contamination of Non-Sterile Products. Class II DLC Laboratories, Inc
Dec 15, 2017 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... Presence of Particulate Matter: identified as polyethylene, which is consistent with the material... Class II B. Braun Medical Inc
Nov 29, 2017 BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long B... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sil... Class I Blue Fusion Natural
Nov 28, 2017 Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titani... CGMP Deviations: products manufactured in a manner that may impact product quality that includes ... Class II EAI-JR286 INC
Nov 9, 2017 GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans Class I Kareway Products Inc
Sep 15, 2017 RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packet... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 15, 2017 PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distribute... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 15, 2017 FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, ... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 15, 2017 grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana See... Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... Class I Gadget Island, Inc
Sep 13, 2017 Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1... Presence of particulate matter: glass flakes identified as lamellae observed during a routine qua... Class II Amgen, Inc.
Sep 5, 2017 ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lo... Class III Aidarex Pharmaceuticals LLC
Sep 5, 2017 Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with... Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. Class I Genentech, Inc.
Sep 5, 2017 Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... Class III Aidarex Pharmaceuticals LLC
Aug 29, 2017 PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, ... Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. Class I Lucky Mart Inc.
Aug 15, 2017 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose ... Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of re... Class II Amphastar Pharmaceuticals, Inc.
Aug 4, 2017 Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subc... Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product ... Class II Amgen, Inc.
Jul 12, 2017 Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... CGMP Deviations Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jun 23, 2017 Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Sl... Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... Class II ImprimisRx CA, Inc., dba ImprimisRx
Jun 23, 2017 Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Dr... Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... Class II ImprimisRx CA, Inc., dba ImprimisRx
Jun 23, 2017 Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml B... Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... Class II ImprimisRx CA, Inc., dba ImprimisRx
Jun 23, 2017 Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Com... Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... Class II ImprimisRx CA, Inc., dba ImprimisRx
Jun 22, 2017 MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sild... Class I Vitility
Apr 18, 2017 BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, suppli... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 co... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg val... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply

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.