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Drug FDA Class II Ongoing Quality

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited Published Aug 6, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact FDC Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Affected products (1)

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

TIMOLOL MALEATE · 154,176 bottles

NDC: 64980-513, 64980-514, 64980-513-05, 64980-513-01, 64980-513-15, 64980-514-05, 64980-514-01, 64980-514-15
Code info: Lot#: 083L061, Exp.: 11/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 5, 2025
  2. Published
    Aug 6, 2025
Recall number
D-0543-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.