Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 2,561–2,580 of 18,047 drug recalls

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

View recall →

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.

View recall →

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 →

Drug Recall Terminated Historical recordClass II

Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).

by Golden State Medical Supply Inc.

Reason
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Recall initiated
May 25, 2023
Reported by FDA
June 14, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

by Viatris Inc

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Recall initiated
May 25, 2023
Reported by FDA
June 14, 2023
Distribution
Product was distributed to 10 distributors who may have further distribute the product to the retail level.

View recall →

Drug Recall Completed Historical recordClass II

ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1

by Empower Clinic Services LLC dba Empower Pharmacy

Reason
Mislabeling: preservative free product labeled as preserved.
Recall initiated
May 12, 2023
Reported by FDA
June 14, 2023
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

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.

Reconnecting to the server…

We lost the connection to the server.

Your session has expired.