Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 1... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx o... | Failed Dissolution Specifications | Class II | Sandoz Inc |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.