Skip to content
Back to recalls
Drug FDA Class II Ongoing Quality

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

FDC Limited Published Aug 28, 2024

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: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Affected products (1)

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

TIMOLOL MALEATE · 176,784 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 #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 12, 2024
  2. Published
    Aug 28, 2024
Recall number
D-0642-2024
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.