Skip to main content
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
Recall details
Location
Date range
Clear filters

Showing 941–960 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.

by Tailstorm Health INC

Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated
June 2, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.

by Tailstorm Health INC

Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated
June 2, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.

by Tailstorm Health INC

Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated
June 2, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.

by Tailstorm Health INC

Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated
June 2, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.

by Tailstorm Health INC

Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated
June 2, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.

by Tailstorm Health INC

Reason
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Recall initiated
June 2, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01

by Advanced Pharmaceutical Technology, Inc.

Reason
Marketed Without an Approved NDA/ANDA
Recall initiated
May 30, 2025
Reported by FDA
July 2, 2025
Distribution
NY, NJ

View recall →

Drug Recall Ongoing Historical recordClass II

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3

by Apotex Corp.

Reason
Lack of Assurance of Sterility
Recall initiated
May 28, 2025
Reported by FDA
July 2, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4

by Apotex Corp.

Reason
Lack of Assurance of Sterility
Recall initiated
May 28, 2025
Reported by FDA
July 2, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2

by Apotex Corp.

Reason
Lack of Assurance of Sterility
Recall initiated
May 28, 2025
Reported by FDA
July 2, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

by B BRAUN MEDICAL INC

Reason
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Recall initiated
June 16, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 27, 2025
Reported by FDA
July 2, 2025
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62

by Pfizer Inc.

Reason
Discoloration; discolored solution from cracked vials
Recall initiated
May 28, 2025
Reported by FDA
July 2, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Reason
Lack of Assurance of Sterility
Recall initiated
May 21, 2025
Reported by FDA
July 2, 2025
Distribution
USA 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.