Public Health Trace

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

Drug Recall Terminated Historical recordClass II

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

by Direct Rx

Reason: cGMP deviations
Recall initiated: March 13, 2023
Reported by FDA: April 5, 2023
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Recall initiated: March 13, 2023
Reported by FDA: April 5, 2023
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.

by Endo Pharmaceuticals, Inc.

Reason: Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Recall initiated: March 2, 2023
Reported by FDA: April 5, 2023
Distribution: Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass I

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

by Global Pharma Healthcare Private Limited

Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Recall initiated: February 24, 2023
Reported by FDA: March 29, 2023
Distribution: Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Content Uniformity Specifications
Recall initiated: March 9, 2023
Reported by FDA: March 29, 2023
Distribution: USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Recall initiated: March 10, 2023
Reported by FDA: March 29, 2023
Distribution: US Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Recall initiated: March 10, 2023
Reported by FDA: March 29, 2023
Distribution: US Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Recall initiated: March 10, 2023
Reported by FDA: March 29, 2023
Distribution: US Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Recall initiated: March 10, 2023
Reported by FDA: March 29, 2023
Distribution: US Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason: Labeling: Label Mix-up
Recall initiated: March 9, 2023
Reported by FDA: March 29, 2023
Distribution: Product was distributed nationwide within the United States and PR

View recall →

Drug Recall Terminated Historical recordClass II

Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01.

by Teva Pharmaceuticals USA Inc

Reason: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Recall initiated: February 23, 2023
Reported by FDA: March 22, 2023
Distribution: Nationwide in the U.S.A.

View recall →

Drug Recall Terminated Historical recordClass III

Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Recall initiated: February 24, 2023
Reported by FDA: March 22, 2023
Distribution: AZ, OH, MS.

View recall →

Drug Recall Terminated Historical recordClass III

Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05

by AVEVA Drug Delivery Systems, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Recall initiated: February 15, 2023
Reported by FDA: March 22, 2023
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05

by AVEVA Drug Delivery Systems, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Recall initiated: February 15, 2023
Reported by FDA: March 22, 2023
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27

by Padagis US LLC

Reason: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Recall initiated: February 21, 2023
Reported by FDA: March 22, 2023
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Potential risk of Cross Contamination
Recall initiated: March 2, 2023
Reported by FDA: March 22, 2023
Distribution: USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Potential risk of Cross Contamination
Recall initiated: March 2, 2023
Reported by FDA: March 22, 2023
Distribution: USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Potential risk of Cross Contamination
Recall initiated: March 2, 2023
Reported by FDA: March 22, 2023
Distribution: USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Potential risk of Cross Contamination
Recall initiated: March 2, 2023
Reported by FDA: March 22, 2023
Distribution: USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Potential risk of Cross Contamination
Recall initiated: March 2, 2023
Reported by FDA: March 22, 2023
Distribution: USA nationwide.

View recall →

Data last updated: November 2, 2026 ET

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.