Tropicamide — Class III drug recall D-0305-2025
Ongoing recall by Imprimis NJOF, LLC, reported 2025-04-09, distributed in FL, NY. Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications
| Recall number | D-0305-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Imprimis NJOF, LLC, Ledgewood, NJ, United States |
| Recall initiated | 2025-02-24 |
| Classified | 2025-03-28 |
| Reported by FDA | 2025-04-09 |
| Distributed | FL, NY |
| Quantity | 2,822 bottles |
| Reason classes | labeling, potency, specification failure |
| NDC | 71384-0733-05 |
| Lot numbers | 24OCT041 |
| Expiration dates | 2025-04-26 |
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.
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-0305-2025. 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.