FDA Reports Class II Recall of Imprimis Intraocular Dexamethasone Injections Due to Glass Particulates

Key Takeaways

• Imprimis NJOF, LLC has initiated 2 nationwide voluntary Class II recalls involving compounded intraocular injections containing dexamethasone in combination with antibiotics and/or nonsteroidal anti-inflammatory drugs (NSAIDs).
• The recalls were triggered by the presence of glass-like particulate matter, posing a potential safety risk if administered intraocularly.
• Both recalls remain ongoing, and pharmacists should review inventory for affected lot numbers and expiration dates.

Imprimis NJOF, LLC is recalling two compounded intraocular injectable drug products distributed nationwide in the US. The first product, Dexamethasone Moxifloxacin Intraocular Injection (1 mg/mL and 5 mg/mL, 1 mL, Rx only; NDC 71384-512-0.1), was distributed in 778 boxes totaling 15 540 pre-filled syringes. A second product, Dexamethasone Moxifloxacin Ketorolac Single-Use Intraocular Injection (1 mg/mL, 0.5 mg/mL, 0.4 mg/mL; NDC 71384-513-01), involved 596 boxes totaling 11 920 pre-filled syringes. Both products were manufactured and distributed by Imprimis NJOF, LLC of Ledgewood, New Jersey.

The FDA has classified both recalls as Class II, indicating that use of or exposure to the affected products may cause temporary or medically reversible adverse health consequences, with the probability of serious outcomes considered remote. The recalls (D-0249-2026 and D-0250-2026) were voluntarily initiated by the firm on December 18, 2025, following identification of glass-like particulate matter in the injections. Affected lots include 25MAY051, 25AUG003, 25APR001A, and 25APR001B, with expiration dates ranging from April through August 2026. Notification to consignees was issued via letter, and no public press release has been issued.

Imprimis NJOF, LLC, a pharmaceutical compounding firm, continues to manage the recalls, which remain ongoing with no termination date announced. Pharmacists should immediately quarantine affected inventory, verify lot numbers and expiration dates, and follow firm instructions for return or disposal. Given the intraocular route of administration, particulate contamination raises concerns for ocular inflammation, irritation, or other complications, underscoring the importance of prompt action at the pharmacy level.

Dexamethasone-based intraocular injections are commonly used in ophthalmic procedures to reduce postoperative inflammation, while moxifloxacin provides antibacterial prophylaxis and ketorolac offers additional nonsteroidal anti-inflammatory pain control. These combination products are typically administered during or after eye surgery to help prevent infection, control inflammation, and manage pain.

Reference

FDA. Enforcement Report. January 14, 2026. Accessed January 15, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm