Olopatadine Recall: USV Private Limited Ophthalmic Solution
Announced 2025-10-29 · FDA
FDA is recalling 8,952 bottles of USV Private Limited Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% distributed nationwide in the United States. The recall is due to failed impurities/degradation specifications; the result for Any individual unspecified impurity exceeded the specification limit. Lot 35000409, Exp. 01/2026 is affected.
| Brand | USV Private Limited |
|---|---|
| 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 |
| Reason | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. |
| Severity | moderate |
| Units affected | 8952 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: 35000409, Exp. Date 01/2026 |
WHAT YOU SHOULD DO
- Stop using any recalled bottles immediately.
- Check the lot number 35000409 and expiry date 01/2026; if they match, contact the retailer or SOLA Pharmaceuticals LLC for instructions on return or disposal.
- Do not discard in household trash; follow local disposal guidelines or return to the place of purchase.
- If you have used the product and have concerns or experience adverse effects, contact your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.