# FDA recall D-0034-2026

> **USV Private Limited** · Class II · drug recall initiated 2025-10-09.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0034-2026
- **Recalling firm:** USV Private Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-09
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dabhel, Daman, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2026

## Citation

> AI Analytics. FDA recall D-0034-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0034-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*