Why it was recalled
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Product description
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Lot numbers, UPCs & expiration codes
Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
Where it was sold
Nationwide in the US
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-0677-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 5, 2025
- FDA report date
- Oct 8, 2025
- Quantity
- 493,468 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0677-2025, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97561
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
- Postal code
- 33326-3253
- Report date
- Oct 8, 2025
- Product type
- Drugs
- Recall number
- D-0677-2025
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 493,468 bottles
- Reason for recall
- Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Sep 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2025