The Recall Desk

FDA (Drugs) recall action 97183

Imprimis NJOF, LLC recalled 2 products on 2025-07-30

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-07-30
Critical
0
Units
9,770

Why these products were recalled

Sub-Potent Drug: Subpotent assay results during stability testing.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2025-07-30

    Compounded quadruple ophthalmic solution returned subpotent assay results in stability testing

    A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.

    Product
    Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2025-07-30

    Compounded epinephrine lidocaine vials returned subpotent assay results in stability testing

    Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.

    Product
    Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
    Category
    Distribution
    0 states