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
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
Apr 18, 2017 ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied i... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, suppl... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count pa... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplie... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, ... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 1... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsu... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 13, 2017 Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.000000000000... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Apr 13, 2017 Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HP... Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... Class I Standard Homeopathic Company
Mar 13, 2017 Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Swit... Superpotent Drug: An oversized tablet was found in a bottle. Class II Genentech Inc.
Feb 16, 2017 SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged i... Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... Class II Sato Pharmaceutical Inc.
Feb 16, 2017 DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL)... Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... Class II Sato Pharmaceutical Inc.
Feb 16, 2017 XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg ... Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tada... Class I Organic Herbal Supply
Feb 16, 2017 Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15... Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... Class II Sato Pharmaceutical Inc.
Feb 10, 2017 TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx

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.