Recall archive / FDA drug enforcement

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, ... — FDA record D-0249-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

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

What the record says

Product: Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Reason: Presence of particulate matter - Glass like particles.
Classification: Class II
Recalling firm: Imprimis NJOF, LLC
Quantity: 778 boxes of 15,540 pre-filled syringes
Agency-reported status: Ongoing
Source record identifier: D-0249-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 14, 2026
Recall initiation date: Dec 18, 2025
Center classification date: Jan 2, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.