Why it was recalled
Lack of Assurance of Sterility
Product description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Lot numbers, UPCs & expiration codes
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
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-0407-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 5, 2026
- FDA report date
- Mar 25, 2026
- Quantity
- 107,136 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0407-2026, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98536
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
- Postal code
- 33326-3253
- Report date
- Mar 25, 2026
- Product type
- Drugs
- Recall number
- D-0407-2026
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 107,136 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Mar 5, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 27, 2026