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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 5,541–5,560 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com and e) SoFi Stadium Wash-Free Hand Sanitizer. UPC 8 19845 00597 8

by Shane Erickson Inc

Reason
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Recall initiated
December 23, 2020
Reported by FDA
February 3, 2021
Distribution
Nationwide USA and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Recall initiated
March 19, 2020
Reported by FDA
January 27, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Recall initiated
November 20, 2020
Reported by FDA
January 27, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Recall initiated
November 20, 2020
Reported by FDA
January 27, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Recall initiated
November 20, 2020
Reported by FDA
January 27, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Recall initiated
November 20, 2020
Reported by FDA
January 27, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.

by Allergan, PLC.

Reason
Labeling: Missing instructions for use insert
Recall initiated
December 30, 2020
Reported by FDA
January 27, 2021
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

by American Health Packaging

Reason
Failed Dissolution Specifications
Recall initiated
January 7, 2021
Reported by FDA
January 27, 2021
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass III

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

by Genus Lifesciences Inc.

Reason
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Recall initiated
December 23, 2020
Reported by FDA
January 20, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.

by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

Reason
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Recall initiated
December 1, 2020
Reported by FDA
January 20, 2021
Distribution
TX

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Drug Recall Ongoing Historical recordClass II

Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02

by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

Reason
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Recall initiated
December 1, 2020
Reported by FDA
January 20, 2021
Distribution
TX

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Drug Recall Terminated Historical recordClass II

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

by Precision Dose Inc.

Reason
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Recall initiated
January 1, 2021
Reported by FDA
January 20, 2021
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01

by Nostrum Laboratories Inc

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated
January 4, 2021
Reported by FDA
January 20, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Recall initiated
March 19, 2020
Reported by FDA
January 20, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

by KVK-Tech, Inc.

Reason
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Recall initiated
December 18, 2020
Reported by FDA
January 20, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

by US Compounding Inc

Reason
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Recall initiated
December 16, 2020
Reported by FDA
January 20, 2021
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

by Sunstar Americas, Inc.

Reason
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Recall initiated
December 28, 2020
Reported by FDA
January 20, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

by Akorn, Inc.

Reason
Defective container: Customer complaints for oral solution leaking from bottles.
Recall initiated
December 28, 2020
Reported by FDA
January 20, 2021
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.