HIGH

Imprimis NJOF Recalls Intraocular Injection Over Glass Particles Hazard

Imprimis NJOF, LLC recalled 596 boxes of intraocular injections on December 18, 2025. The recall affects products due to the presence of glass-like particles. Consumers should stop using the product immediately and contact their healthcare provider.

Quick Facts at a Glance

Recall Date
December 18, 2025
Hazard Level
HIGH
Brand
Imprimis NJOF
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Presence of particulate matter - Glass like particles.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Imprimis NJOF, LLC or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL, with model numbers Lot: 25APR001A and 25APR001B. The expiration date is April 3, 2026. The product was distributed nationwide in the U.S.

The Hazard

The recall addresses the presence of particulate matter in the product, specifically glass-like particles. These particles pose a risk of injury if injected, leading to potential complications.

Reported Incidents

There are no specific incident reports or injuries mentioned related to this recall. The potential for harm is classified as high due to the nature of the particulate hazard.

What to Do

Consumers and healthcare providers should stop using the recalled product immediately. For further guidance, contact Imprimis NJOF, LLC or your healthcare provider directly.

Contact Information

For questions, consumers can contact Imprimis NJOF, LLC at their facility located at 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. More information is available at the FDA's recall notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0250-2026.

Key Facts

  • Recalled brand: Imprimis NJOF
  • Total units recalled: 596 boxes
  • Each box contains 11,920 pre-filled syringes
  • Recall initiated on December 18, 2025
  • Stop using product immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot: 25APR001A
25APR001B
Affected States
ALL
Report Date
January 14, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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