Mydriatic-4 Eye Drops (Imprimis) – Subpotent Medication (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Brand
Imprimis NJOF, LLC
Lot Codes / Batch Numbers
Lot#s: 22DEC065 (MDU), exp: 09/29/2023, 23JAN024 (MDU), exp: 10/13/2023, 23FEB024 (SDU), exp: 11/09/2023, 23MAR013 (SDU), exp: 12/01/2023, 23MAR033 (SDU), exp: 12/16/2023, 23MAY044 (SDU), exp: 03/23/2024
Products Sold
Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
Imprimis NJOF, LLC is recalling MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drop due to Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026