Reported Aug 6, 2025 · Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj,…
FDC Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FDC Limited · B-8 MIDC Industrial Area · Aurangabad, Maharashtra State · N/A
Is this the product you have?
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only
- Manufactured byFDC Limited, Waluj, Aurangabad, Maharashtra, India
- Distributed byRising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05
- Lot codes and dates
Lot#: 083L061Exp.: 11/2025
- Amount recalled
- 154,176 bottles
Where it was sold
- Nationwide
Why it was recalled
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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