Recalls / Class II
Class IID-0543-2025
Product
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.
- Brand name
- Timolol Maleate
- Generic name
- Timolol Maleate
- Active ingredient
- Timolol Maleate
- Route
- Ophthalmic
- NDCs
- 64980-513, 64980-514
- FDA application
- ANDA077259
- Affected lot / code info
- Lot#: 083L061, Exp.: 11/2025.
Why it was recalled
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Recalling firm
- Firm
- FDC Limited
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, N/A, India
Distribution
- Quantity
- 154,176 bottles
- Distribution pattern
- U.S Nationwide.
Timeline
- Recall initiated
- 2025-07-05
- FDA classified
- 2025-07-29
- Posted by FDA
- 2025-08-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0543-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.