Drug FDA Class II Ongoing Failed specifications
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
USV Private Limited Published Oct 29, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact USV Private Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Hazards
Unspecified Impurity · primary
Affected products (1)
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
8,952 bottles
Code info: Lot #: 35000409, Exp. Date 01/2026
Affected areas
Nationwide
Timeline
- InitiatedOct 9, 2025
- PublishedOct 29, 2025
- Recall number
- D-0034-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.