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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 5,901–5,920 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,

by Ultra Seal Corporation

Reason
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Recall initiated
August 3, 2020
Reported by FDA
August 26, 2020
Distribution
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.

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Drug Recall Terminated Historical recordClass III

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007

by Ultra Seal Corporation

Reason
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Recall initiated
August 3, 2020
Reported by FDA
August 26, 2020
Distribution
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.

View recall →

Drug Recall Terminated Historical recordClass I

ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01

by CareFusion 213, LLC

Reason
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Recall initiated
June 23, 2020
Reported by FDA
August 26, 2020
Distribution
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,

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Drug Recall Terminated Historical recordClass I

ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11

by CareFusion 213, LLC

Reason
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Recall initiated
June 23, 2020
Reported by FDA
August 26, 2020
Distribution
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,

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Drug Recall Terminated Historical recordClass I

BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32

by CareFusion 213, LLC

Reason
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Recall initiated
June 23, 2020
Reported by FDA
August 26, 2020
Distribution
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,

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Drug Recall Terminated Historical recordClass II

Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37

by Lannett Company, Inc.

Reason
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Recall initiated
August 10, 2020
Reported by FDA
August 26, 2020
Distribution
US Nationwide

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Drug Recall Ongoing Historical recordClass II

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

by Sanofi-Aventis U.S. LLC

Reason
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Recall initiated
August 10, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass I

STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00

by Ferring Pharmaceuticals Inc

Reason
Superpotent Drug
Recall initiated
July 21, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass I

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05

by Ferring Pharmaceuticals Inc

Reason
Superpotent Drug
Recall initiated
July 21, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass I

DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0

by Ferring Pharmaceuticals Inc

Reason
Superpotent Drug
Recall initiated
July 21, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass I

All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0

by Itech 361 LLC

Reason
Chemical Contamination: Product contains undeclared methanol.
Recall initiated
June 23, 2020
Reported by FDA
August 19, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Recall initiated
July 21, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5

by Eosera, Inc.

Reason
cGMP Deviations.
Recall initiated
August 4, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125

by Eosera, Inc.

Reason
cGMP Deviations.
Recall initiated
August 4, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2

by Eosera, Inc.

Reason
cGMP Deviations.
Recall initiated
August 4, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8

by Eosera, Inc.

Reason
cGMP Deviations.
Recall initiated
August 4, 2020
Reported by FDA
August 19, 2020
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.