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 461–480 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas

by Owen Biosciences Inc.

Reason
Chemical contamination: Presence of benzene
Recall initiated
March 3, 2026
Reported by FDA
April 22, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

by Cipla USA, Inc.

Reason
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Recall initiated
March 16, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

by Cipla USA, Inc.

Reason
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Recall initiated
March 16, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

by Cipla USA, Inc.

Reason
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Recall initiated
March 16, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch

by Teva Pharmaceuticals USA, Inc

Reason
CGMP Deviations: use of an unapproved raw material
Recall initiated
March 19, 2026
Reported by FDA
April 15, 2026
Distribution
Within U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch

by Teva Pharmaceuticals USA, Inc

Reason
CGMP Deviations: use of an unapproved raw material
Recall initiated
March 19, 2026
Reported by FDA
April 15, 2026
Distribution
Within U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch

by Teva Pharmaceuticals USA, Inc

Reason
CGMP Deviations: use of an unapproved raw material
Recall initiated
March 19, 2026
Reported by FDA
April 15, 2026
Distribution
Within U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

by GE Healthcare Ireland Limited

Reason
Presence of particulate matter
Recall initiated
March 24, 2026
Reported by FDA
April 15, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

by GE Healthcare Ireland Limited

Reason
Presence of particulate matter
Recall initiated
March 24, 2026
Reported by FDA
April 15, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

by Teva Pharmaceuticals USA, Inc

Reason
Superpotent and Subpotent
Recall initiated
January 12, 2026
Reported by FDA
April 15, 2026
Distribution
FL, OH, PR & MS

View recall →

Drug Recall Ongoing 2026 recordClass II

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

by Teva Pharmaceuticals USA, Inc

Reason
Superpotent and Subpotent
Recall initiated
January 12, 2026
Reported by FDA
April 15, 2026
Distribution
FL, OH, PR & MS

View recall →

Drug Recall Ongoing 2026 recordClass II

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

by Viatris, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
March 17, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

by Preferred Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 25, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

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.

Reconnecting to the server…

We lost the connection to the server.

Your session has expired.