FDA Recall D-0543-2025
FDC Limited
Class II Ongoing 313 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Recall record
- Recall number
D-0543-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S Nationwide.
- Recall initiated
- 2025-07-05
- Classified by FDA Center
- 2025-07-29
- FDA published
- 2025-08-06
- Recalling firm
- FDC Limited
Drug identification
- Brand name(s)
- TIMOLOL MALEATE
- Generic name(s)
- TIMOLOL MALEATE
- Manufacturer(s)
- Rising Pharma Holdings, Inc.
- NDC(s)
64980-513, 64980-514- Route(s)
- OPHTHALMIC
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.