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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 4,021–4,040 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Recall initiated
April 29, 2022
Reported by FDA
May 18, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Recall initiated
April 29, 2022
Reported by FDA
May 18, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass I

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Recall initiated
March 4, 2022
Reported by FDA
May 18, 2022
Distribution
Nationwide USA and Puerto Rico, Canada, Columbia, France

View recall →

Drug Recall Terminated Historical recordClass II

MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01

by Amgen, Inc.

Reason
Defective container: loose crimp defect, potential loss of container integrity.
Recall initiated
May 2, 2022
Reported by FDA
May 18, 2022
Distribution
Nationwide in the USA, Egypt and Lithuania.

View recall →

Drug Recall Terminated Historical recordClass II

Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.

by Viatris Inc

Reason
Failed Dissolution Specifications: low out of specification results for dissolution.
Recall initiated
April 28, 2022
Reported by FDA
May 18, 2022
Distribution
Product was distributed nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02

by Best Brands Consumer Products, Inc.

Reason
Chemical Contamination; FDA analysis found product to contain benzene
Recall initiated
March 29, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02

by Best Brands Consumer Products, Inc.

Reason
Chemical Contamination; FDA analysis found product to contain methanol
Recall initiated
March 29, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
OH

View recall →

Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

by Torrent Pharma Inc

Reason
CGMP deviations: tablets cracking
Recall initiated
April 11, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Ongoing Historical recordClass II

Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68

by McKesson Corporation dba McKesson Drug Company

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recall initiated
April 21, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.

View recall →

Drug Recall Ongoing Historical recordClass II

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65

by McKesson Corporation dba McKesson Drug Company

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recall initiated
April 21, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66

by McKesson Corporation dba McKesson Drug Company

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recall initiated
April 21, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64

by McKesson Corporation dba McKesson Drug Company

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recall initiated
April 21, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.

View recall →

Drug Recall Ongoing Historical recordClass II

Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67

by McKesson Corporation dba McKesson Drug Company

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recall initiated
April 21, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.

View recall →

Drug Recall Terminated Historical recordClass III

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

by Akorn, Inc.

Reason
Failed viscosity specification - product was below specificcation
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.

by Viatris Inc

Reason
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Recall initiated
April 28, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
March 31, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
March 31, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
March 31, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
March 31, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed 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.