Recalls / Class II

Class IID-0249-2026

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

Affected lot / code info

Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026

Why it was recalled

Presence of particulate matter - Glass like particles.

Recalling firm

Firm

Imprimis NJOF, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1705 Route 46 Ste 6B, Ledgewood, New Jersey 07852-9720

Distribution

Quantity

778 boxes of 15,540 pre-filled syringes

Distribution pattern

U.S Nationwide

Timeline

Recall initiated

2025-12-18

FDA classified

2026-01-02

Posted by FDA

2026-01-14

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0249-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.