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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
May 31, 2019 Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (4... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 16... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 22, 2019 Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... Failed Impurities/Degradation Specifications. Class III Fresenius Kabi USA, LLC
May 6, 2019 Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceutica... Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class II Geritrex, LLC
May 6, 2019 Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Ger... Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class II Geritrex, LLC
Apr 30, 2019 Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl... Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product Class I Par Pharmaceutical, Inc.
Apr 29, 2019 Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ... Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax... Class III Pfizer Inc.
Mar 29, 2019 Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, ... Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration... Class III X-Gen Pharmaceuticals Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 15, 2019 Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 m... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Dist... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged i... Defective container: Ineffective seal between the cap and jar of the affected product. Class III Estee Lauder Inc
Mar 15, 2019 Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL)... Presence of Particulate Matter; glass particulates Class I Pfizer Inc.
Mar 15, 2019 Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 7, 2019 Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the foll... Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items con... Class II Medtech Products, Inc.
Mar 5, 2019 LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containi... Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approve... Class I USA LESS Inc.
Feb 13, 2019 Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, ... Failed Degradation/Impurities Specifications: Out of specification related substance results duri... Class III Perrigo New York, Inc.
Dec 6, 2018 Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle... Superpotent Drug. Class II Pfizer Inc.
Dec 4, 2018 Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic... Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottl... Class II Epic Pharma, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured b... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30),... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-11... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 19, 2018 Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 19, 2018 children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIS... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., Inc.
Oct 3, 2018 Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g T... Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Hep... Class II Pfizer Inc.
Oct 3, 2018 Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... Class III InvaGen Pharmaceuticals, Inc.
Sep 20, 2018 Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx ... CGMP Deviations; rejected product was used to manufacture final bulk lot Class II Pfizer Inc.
Sep 20, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... Lack of assurance of sterility: loss of container integrity. Class II Pfizer Inc.
Sep 19, 2018 Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, ... Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Th... Class II Pfizer Inc.
Sep 6, 2018 Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30... Failed impurities/degradation specifications: Finished product contain a known product impurity a... Class III Par Pharmaceutical, Inc.
Sep 6, 2018 Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottl... Failed impurities/ degradation specifications: Out-of-specification results were observed in the ... Class III InvaGen Pharmaceuticals, Inc.
Aug 28, 2018 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... Class III Pfizer Inc.
Aug 22, 2018 THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 22, 2018 THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Jul 25, 2018 alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g ... Microbial Contamination of a Non-Sterile Product Class II The Hain Celestial Group, Inc. - Worldwide HQ
Jul 5, 2018 alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9... Incorrect Product Formulation: wrong sunscreen product in the package. Class II The Hain Celestial Group, Inc. - Worldwide HQ
May 7, 2018 Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, D... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC

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.