Public Health Trace

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

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.

by Optikem International, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: February 29, 2024
Reported by FDA: March 20, 2024
Distribution: Product distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

by Thea Pharma, Inc.

Reason: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Recall initiated: March 5, 2024
Reported by FDA: March 20, 2024
Distribution: Product was distributed nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiated: February 7, 2024
Reported by FDA: March 20, 2024
Distribution: Product was distributed to three direct accounts in NM, AZ and UT.

View recall →

Drug Recall Terminated Historical recordClass II

Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiated: February 7, 2024
Reported by FDA: March 20, 2024
Distribution: Product was distributed to three direct accounts in NM, AZ and UT.

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiated: February 7, 2024
Reported by FDA: March 20, 2024
Distribution: Product was distributed to three direct accounts in NM, AZ and UT.

View recall →

Drug Recall Terminated Historical recordClass II

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20

by B. Braun Medical Inc

Reason: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Recall initiated: March 6, 2024
Reported by FDA: March 20, 2024
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: March 4, 2024
Reported by FDA: March 20, 2024
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: March 4, 2024
Reported by FDA: March 20, 2024
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com

by Stason Pharmaceuticals, Inc.

Reason: Failed Dissolution Specifications: results slightly under spec at at 9-months.
Recall initiated: February 9, 2024
Reported by FDA: March 13, 2024
Distribution: USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01

by Eugia US LLC

Reason: Failed Dissolution Specifications
Recall initiated: February 20, 2024
Reported by FDA: March 13, 2024
Distribution: OH, TN, LA, MS

View recall →

Drug Recall Ongoing Historical recordClass III

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60

by Contract Pharmaceuticals Limited Canada

Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recall initiated: February 20, 2024
Reported by FDA: March 13, 2024
Distribution: Nationwide in the U.S. and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass III

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

by Contract Pharmaceuticals Limited Canada

Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recall initiated: February 20, 2024
Reported by FDA: March 13, 2024
Distribution: Nationwide in the U.S. and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

by Denver Solutions, LLC DBA Leiters Health

Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiated: February 20, 2024
Reported by FDA: March 6, 2024
Distribution: Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

by Denver Solutions, LLC DBA Leiters Health

Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiated: February 20, 2024
Reported by FDA: March 6, 2024
Distribution: Nationwide in the USA

View recall →

Data last updated: November 1, 2026 ET

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.