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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 2,861–2,880 of 17,937 drug recalls

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.

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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

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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

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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.

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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.

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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.

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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.

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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.

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Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, 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.

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Drug Recall Ongoing Historical recordClass II

Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5

by Pharmedica USA, LLC

Reason
CGMP Deviations
Recall initiated
February 14, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA and Worldwide through e-commerce and trade shows

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Drug Recall Ongoing Historical recordClass I

Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.

by Pharmedica USA, LLC

Reason
Non-Sterility
Recall initiated
February 14, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA and Worldwide through e-commerce and trade shows

View recall →

Drug Recall Ongoing Historical recordClass I

Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.

by Nanomaterials Discovery Corporation

Reason
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Recall initiated
February 14, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1

by Akron Pharma, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 17, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756

by Ecometics, Inc.

Reason
CGMP DEVIATIONS
Recall initiated
February 24, 2023
Reported by FDA
March 15, 2023
Distribution
Nationwide within the United States

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.