Browse Drug Recalls

1,110 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,110 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 1,110 FDA drug recalls in CA.

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DateProductReasonClassFirm
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
Sep 20, 2016 Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Co... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 20, 2016 Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Wa... Lack of Assurance of Sterility; all compounded products within expiry produced using recalled fil... Class II Leiter's Compounding
Sep 2, 2016 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. Class I United Exchange Corporation
Sep 2, 2016 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby... Lack of assurance of sterility Class II United Exchange Corporation
Sep 2, 2016 Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp... Lack of assurance of sterility Class II United Exchange Corporation
Aug 23, 2016 Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: ... Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out... Class III Stason Pharmaceuticals, Inc.
Aug 19, 2016 Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister... Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl... Class I Impax Laboratories, Inc.
Aug 3, 2016 Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per ... Failed Dissolution Specifications: Out-of-specification results in retained sample. Class II Golden State Medical Supply Inc.
Aug 3, 2016 Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules p... Failed Dissolution Specifications: Out-of-specification results in retained sample. Class II Golden State Medical Supply Inc.

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.