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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 2,441–2,460 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02

by Homeocare Laboratories, Inc.

Reason
cGMP deviations
Recall initiated
June 5, 2023
Reported by FDA
July 5, 2023
Distribution
Product was distributed USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03

by Ferring Pharmaceuticals Inc

Reason
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Recall initiated
June 12, 2023
Reported by FDA
July 5, 2023
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

by The Harvard Drug Group

Reason
Packaging defect: blister packaging inadequately sealed.
Recall initiated
June 16, 2023
Reported by FDA
July 5, 2023
Distribution
Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass I

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Recall initiated
May 31, 2023
Reported by FDA
June 28, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
May 18, 2023
Reported by FDA
June 28, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Recall initiated
May 30, 2023
Reported by FDA
June 21, 2023
Distribution
LA, PA and OH.

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Drug Recall Ongoing Historical recordClass III

Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

by AVKARE LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiated
June 13, 2023
Reported by FDA
June 21, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.

by Jarman's Midwest Cleaning Systems, Inc.

Reason
Chemical Contamination: FDA testing found Presence of methanol
Recall initiated
March 27, 2023
Reported by FDA
June 21, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.

by Jarman's Midwest Cleaning Systems, Inc.

Reason
Chemical Contamination: FDA testing found Presence of methanol
Recall initiated
March 27, 2023
Reported by FDA
June 21, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01

by Jarman's Midwest Cleaning Systems, Inc.

Reason
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Recall initiated
March 27, 2023
Reported by FDA
June 21, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30

by Amring Pharmaceuticals Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiated
June 12, 2023
Reported by FDA
June 21, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

by HF Acquisition Co LLC

Reason
Labeling: Label Mix-up
Recall initiated
June 6, 2023
Reported by FDA
June 14, 2023
Distribution
Distributed in TX, AZ and CA only

View recall →

Drug Recall Terminated Historical recordClass II

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
CGMP Deviations
Recall initiated
May 3, 2023
Reported by FDA
June 14, 2023
Distribution
Product was distributed to 19 distributors 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.