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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 4,861–4,880 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.

by Teva Pharmaceuticals USA

Reason
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Recall initiated
September 22, 2021
Reported by FDA
October 27, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08

by Teva Pharmaceuticals USA

Reason
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Recall initiated
September 22, 2021
Reported by FDA
October 27, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)

by American Health Packaging

Reason
Failed Dissolution Specifications: results were above specification.
Recall initiated
September 17, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide within the USA

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Drug Recall Terminated Historical recordClass II

Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41

by Piramal Critical Care, Inc.

Reason
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Recall initiated
September 10, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3

by Sanitor Corporation

Reason
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Recall initiated
September 21, 2021
Reported by FDA
October 27, 2021
Distribution
Distributed to one distributor located in Las Vegas, NV.

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Drug Recall Terminated Historical recordClass II

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

by Beiersdorf Inc

Reason
cGMP Deviations
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

by Beiersdorf Inc

Reason
cGMP Deviations
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0

by Beiersdorf Inc

Reason
cGMP Deviations
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass I

Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9

by Beiersdorf Inc

Reason
Chemical contamination; presence of benzene
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1

by Beiersdorf Inc

Reason
Chemical contamination; presence of benzene
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

by Beiersdorf Inc

Reason
Chemical contamination; presence of benzene
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

by Beiersdorf Inc

Reason
Chemical contamination; presence of benzene
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0

by Beiersdorf Inc

Reason
Chemical contamination; presence of benzene
Recall initiated
September 30, 2021
Reported by FDA
October 27, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01

by Eli Lilly & Company

Reason
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Recall initiated
September 24, 2021
Reported by FDA
October 20, 2021
Distribution
Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico

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Drug Recall Terminated Historical recordClass II

Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason
Lack of Assurance of Sterility
Recall initiated
September 22, 2021
Reported by FDA
October 20, 2021
Distribution
MO

View recall →

Drug Recall Terminated Historical recordClass II

Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.

by Strides Pharma Inc.

Reason
Failed Dissolution Specifications
Recall initiated
September 27, 2021
Reported by FDA
October 20, 2021
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

by RISING PHARMACEUTICALS

Reason
Labeling: Incorrect Instructions
Recall initiated
September 2, 2021
Reported by FDA
October 13, 2021
Distribution
to be entered

View recall →

Drug Recall Terminated Historical recordClass II

Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11

by Akorn, Inc.

Reason
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Recall initiated
October 4, 2021
Reported by FDA
October 13, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.

by Azurity Pharmaceuticals, Inc.

Reason
Product Mix-up: Incorrect diluent component included in the kit.
Recall initiated
August 24, 2021
Reported by FDA
October 13, 2021
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.

by AMIVAS (US), LLC

Reason
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Recall initiated
September 27, 2021
Reported by FDA
October 13, 2021
Distribution
Product was distributed to 3 major distributors who may have further distributed the product to various medical centers, hospitals and hospital pharmacies nationwide in the USA.

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.