Multi-event December 2025 FDA Recall Drug by Imprimis Njof, Llc

This Multi-event Class II drug recall was voluntarily initiated by Imprimis Njof, Llc on December 18, 2025 for the product Drug. The FDA reported the reason for recall as presence of particulate matter - glass like particles.. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-0251-2026 ONGOING D-0250-2026 ONGOING D-0249-2026 ONGOING

Recall Number: D-0251-2026

Reason for Recall
Presence of particulate matter - Glass like particles.
Initiated
12-18-2025
Reported
01-14-2026
Quantity
314 boxes of 6,280 pre-filled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Imprimis NJOF, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S Nationwide
Product Description About Product Description
Full technical description of the product.
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Batch or Lot Expiration Information

Lot# Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.

Recall Number: D-0250-2026

Reason for Recall
Presence of particulate matter - Glass like particles.
Initiated
12-18-2025
Reported
01-14-2026
Quantity
596 boxes of 11,920 pre-filled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Imprimis NJOF, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S Nationwide
Product Description About Product Description
Full technical description of the product.
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

Batch or Lot Expiration Information

Lot# Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.

Recall Number: D-0249-2026

Reason for Recall
Presence of particulate matter - Glass like particles.
Initiated
12-18-2025
Reported
01-14-2026
Quantity
778 boxes of 15,540 pre-filled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98181
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Imprimis NJOF, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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