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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
Jan 24, 2022 REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, ... cGMP deviations Class II Ultra Seal Corporation
Dec 15, 2021 Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria Class I Taro Pharmaceuticals U.S.A., Inc.
Dec 6, 2021 kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Valisa MFG LLC
Nov 30, 2021 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... Lack of sterility assurance: bag has the potential to leak. Class II Pfizer Inc.
Nov 29, 2021 PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... CGMP Deviations: failed stability results, inadequate laboratory investigations, Class II ULTRAtab Laboratories, Inc.
Nov 19, 2021 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... Product Mix-up Class II Ascent Pharmaceuticals, Inc.
Nov 12, 2021 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 4, 2021 Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bot... Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Class II Amneal Pharmaceuticals of New York, LLC
Nov 4, 2021 Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bott... Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Class II Amneal Pharmaceuticals of New York, LLC
Oct 13, 2021 PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Aug 13, 2021 Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II Pfizer Inc.
Aug 13, 2021 Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... Class II 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.