Why it was recalled
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: 083L061, Exp.: 11/2025.
Where it was sold
U.S Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0543-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 5, 2025
- FDA report date
- Aug 6, 2025
- Quantity
- 154,176 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0543-2025, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Ongoing
- Country
- India
- Event ID
- 97219
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot#: 083L061, Exp.: 11/2025.
- Report date
- Aug 6, 2025
- Product type
- Drugs
- Recall number
- D-0543-2025
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 154,176 bottles
- Reason for recall
- Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S Nationwide.
- Recall initiation date
- Jul 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 29, 2025