Why it was recalled
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Product description
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
Lot numbers, UPCs & expiration codes
Lot #: 35000409, Exp. Date 01/2026
Where it was sold
Nationwide within the United States
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-0034-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 9, 2025
- FDA report date
- Oct 29, 2025
- Quantity
- 8,952 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- USV Private Limited
Original FDA data
Every field from FDA enforcement report D-0034-2026, exactly as published.
Show all FDA fields
- City
- Dabhel, Daman
- Status
- Ongoing
- Country
- India
- Event ID
- 97766
- Address
- H-13, 16, 16a, 17, 18, 19, 20, 21 & E-22, Oidc, Mahatma Gandhi Udyog Nagar
- Code information
- Lot #: 35000409, Exp. Date 01/2026
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0034-2026
- Classification
- Class II
- Recalling firm
- USV Private Limited
- Product quantity
- 8,952 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 9, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 20, 2025