Olopatadine Hydrochloride Ophthalmic Solution USP 0 — Class II drug recall D-0034-2026
Ongoing recall by USV Private Limited, reported 2025-10-29, distributed nationwide. Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the
| Recall number | D-0034-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | USV Private Limited, Dabhel, Daman, India |
| Recall initiated | 2025-10-09 |
| Classified | 2025-10-20 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 8,952 bottles |
| Reason classes | specification failure |
| NDC | 70512-0520-05 |
| Lot numbers | 35000409 |
| Expiration dates | 2026-01 |
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 for recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0034-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.