FDA Drugs recall ·
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %… recall
- Recall number
- D-0034-2026
- Date
- (initiated October 9, 2025)
- Company / brand
- USV Private Limited
H-13, 16, 16a, 17, 18, 19, 20, 21 & E-22, Oidc, Mahatma Gandhi Udyog Nagar, Dabhel, Daman, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8,952 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 35000409, Exp. Date 01/2026
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0034-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.