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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

1,034 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,034 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 1,034 FDA drug recalls in NY.

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DateProductReasonClassFirm
Mar 3, 2014 Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only... Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... Class III Novartis Pharmaceuticals Corp.
Feb 26, 2014 Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 cou... Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphe... Class III Pfizer Us Pharmaceutical Group
Feb 14, 2014 CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals... Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrullin... Class I Medisca Inc
Jan 29, 2014 GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, ... Defective Container: Tamper evident ring failures discovered on some bottles. Class II Pfizer Inc.
Jan 29, 2014 Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E... Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% ra... Class III Fougera Pharmaceuticals Inc.
Jan 22, 2014 Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per... Subpotent; 18 month time point Class II Fresenius Kabi USA, LLC
Jan 16, 2014 ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, N... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops,... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile,... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 2, 2014 Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.... Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of spec... Class III Pfizer Inc.
Nov 18, 2013 KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division o... Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. Class III Fougera Pharmaceuticals Inc.
Nov 4, 2013 Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R... Failed Dissolution Specification; 8 hr stability timepoint Class III Pfizer Inc.
Oct 28, 2013 Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... Failed Stability Specification; product viscosity and or pH are below specification. Class III Hi-Tech Pharmacal Co., Inc.
Oct 16, 2013 Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm... Subpotent. drug Class III Taro Pharmaceuticals U.S.A., Inc.
Sep 6, 2013 Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottl... Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact ... Class I Altaire Pharmaceuticals, Inc.
Sep 5, 2013 Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL s... Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility ass... Class II Fallon Wellness Pharmacy Llc
Sep 4, 2013 GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-... Subpotent; phenylephrine HCl Class III Hi-Tech Pharmacal Co., Inc.
Sep 4, 2013 Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, ... Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... Class II Pfizer Us Pharmaceutical Group
Aug 17, 2013 Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne... Failed dissolution specifications; 18 month CRT Class II Amneal Pharmaceuticals of New York, LLC.
Aug 8, 2013 Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-N... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bo... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physicia... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 ... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 table... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 5, 2013 Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powde... Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desme... Class I Bethel Nutritional Consulting, Inc
Aug 5, 2013 Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear s... Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-d... Class I Bethel Nutritional Consulting, Inc
Jul 31, 2013 Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Ch... Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this produ... Class I Healthy Life Chemistry Inc dba Purity First
Jul 31, 2013 B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, ... Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclare... Class I Healthy Life Chemistry Inc dba Purity First
Jul 25, 2013 Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab... Class III Hi-Tech Pharmacal Co., Inc.
Jul 22, 2013 METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic ... Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid an... Class I Mira Health Products Ltd.
Jul 22, 2013 B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count ... Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine whic... Class I Mira Health Products Ltd.
Jul 22, 2013 Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle ... Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17... Class I Mira Health Products Ltd.
Jun 27, 2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... Class III Max Huber Research Labs, Inc.
Jun 27, 2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... Class III Max Huber Research Labs, Inc.
Jun 27, 2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... Class III Max Huber Research Labs, Inc.
Jun 17, 2013 ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... Class I Advance Pharmaceutical Inc
Jun 11, 2013 Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. ... Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibut... Class I Bethel Nutritional Consulting, Inc
May 31, 2013 Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.... Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogen... Class III Pfizer 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.