# FDA recall D-0305-2025

> **Imprimis NJOF, LLC** · Class III · drug recall initiated 2025-02-24.

## Product

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5%  2.5%  0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

## Reason for recall

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

## Distribution

FL and NY

## Key facts

- **Recall number:** D-0305-2025
- **Recalling firm:** Imprimis NJOF, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-02-24
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ledgewood, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2025

## Citation

> AI Analytics. FDA recall D-0305-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0305-2025. Source: US FDA. Licensed CC0.

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