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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
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
Feb 10, 2017 MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydro... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, kojic acid 3%, hydroc... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CR... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CRE... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRI-BLEACHING CREAM HQ (retinoic Acid 0.05%, Hydroquinone 6%, Fluocinolone 0.... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%)... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 9... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 50... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLY... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%), Rx only, Syner... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5... 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 4%, Fluocinolone 0.01%... 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.