Browse Drug Recalls
1,120 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,120 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 1,120 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2017 | KETOCONAZOLE 2%/HYDROCORTISONE 1.5% 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 | QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hyd... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego,... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego,... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only,... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%,... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in al... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | FIRM AND FADE (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 | HCG and HCG with resveratrol Human Chorionic Gonadotropin in different streng... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| 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 |
| Dec 15, 2016 | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused p... | Lack of Assurance of Sterility: Potential cracks in glass vials | Class II | Amgen, Inc. |
| Dec 13, 2016 | Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immu... | Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled... | Class I | Pacific Medical Solutions |
| Nov 30, 2016 | MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Sta... | Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active... | Class I | MS Bionic |
| Sep 20, 2016 | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL ... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (In... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Vo... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal In... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
| Sep 20, 2016 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL T... | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... | Class II | Leiter's Compounding |
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.