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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

1,091 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,091 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 1,091 FDA drug recalls in CA.

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DateProductReasonClassFirm
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.
Jul 5, 2016 Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chlorid... Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant cl... Class II Let's Talk Health, Inc.
Jun 28, 2016 DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... Class III Golden State Medical Supply Inc.
Jun 1, 2016 CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. ... Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. Class II Aidarex Pharmaceuticals LLC
Jun 1, 2016 Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. Class III Aidarex Pharmaceuticals LLC
Jun 1, 2016 CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... Class III Aidarex Pharmaceuticals LLC
Mar 25, 2016 All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUND... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RE... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDIN... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDI... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMP... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE C... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABL... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOU... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016 All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COM... Lack of Processing Controls Class II Reliable Rexall-A Compounding Pharmacy

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.