Browse Drug Recalls

1,091 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,091 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 1,091 FDA drug recalls in CA.

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DateProductReasonClassFirm
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
Feb 10, 2017 RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETIN... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arb... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 49... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / P... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A Sa... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, S... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx on... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd #... 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.