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Browse Drug Recalls

81 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 81 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 81 FDA drug recalls.

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DateProductReasonClassFirm
Feb 10, 2017 ENHANCED RETIN ANTI-WRINKLE 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 CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARI... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, R... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 490... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE SOLUTION in all strengths including 4%, 28%, Rx only, Synergy ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx o... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MALEK'S MAGIC (retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, hydrocort... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortison... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 VITAMIN K OXIDE 5%, HQ 4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena B... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SULFUR 5% CREAM, 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 AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Die... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 UREA 40% Cream, 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 ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, EN... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINON... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ULTRA LITE CREAM (Hydroquinone 8%), Rx only, Synergy RX, 4901 Morena Blvd # 5... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd #... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San D... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Bl... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%)... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 1... 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.