FDA Recalls Subpotent Epinephrine Injectable for Intraocular Surgical Use
Imprimis NJOF is recalling an epinephrine-lidocaine injectable due to failed potency testing, affecting nationwide distribution. The product was compounded in April 2023 for use during eye surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a confirmed product potency defect in a critical injectable medication used during eye surgery. While no illnesses or injuries have been reported, the subpotency presents a clear risk of inadequate hemostasis and surgical complications, meeting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine HCl injectable (0.25mg/mL and 7.5mg/mL), a preservative-free intraocular injection used during eye surgery. The affected product has lot number 23APR018, compounded on April 24, 2023, with an expiration date of April 17, 2024. The recall involves 364 bags nationwide, with each bag containing 20 vials of 1 mL each.
The product was recalled because it failed potency testing and is subpotent—meaning the epinephrine content is below the labeled specification. This deficiency could result in inadequate drug effectiveness during intraocular surgical procedures where precise vasoconstriction is necessary.
Healthcare facilities and individuals who received product from this lot should be aware of the recall. Any adverse events associated with use of this product should be reported to the FDA through MedWatch at www.fda.gov/medwatch or by telephone at (800) FDA-1088.
The recalled product
- Product
- Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic Injectable
- Hazard
- sub-potency
- product-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 23APR018
Distribution
Distributed nationwide across the United States.
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