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Drug FDA Class II Ongoing Foreign material

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.

Imprimis NJOF, LLC Published Jan 14, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Imprimis NJOF, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of particulate matter - Glass like particles.

Hazards

Glass Particulate · primary

Affected products (1)

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.

596 boxes of 11,920 pre-filled syringes

Lot codes: 25APR001A
Code info: Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 18, 2025
  2. Published
    Jan 14, 2026
Recall number
D-0250-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.