Imprimis NJOF, LLC recall records

15 reported ongoing

20 records in this archive. Latest source date Dec 18, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

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, Led...

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.

Class IIIReported ongoing

Distribution: FL and NY

Official source for Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% ...
FDA drug enforcement

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, Un...

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Class IIIReported terminated

Distribution: Product was distributed to physician's offices nationwide.

Official source for MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution D...

Reasons in these listed records

  • Presence of particulate matter - Glass like particles.
  • Subpotent Drug
  • Sub-Potent Drug: Subpotent assay results during stability testing.
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking Imprimis NJOF, LLC

Is there a recall on imprimis njof, llc right now?

This archive contains 20 records, including 15 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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