Lower riskDrug recall · FDA · Published April 10, 2024
Imprimis Epinephrine-Lidocaine Vials Recalled Due to Assay Inaccuracy
Imprimis NJOF recalls specific epinephrine-lidocaine vials for assay inaccuracies. These prescription-only vials may not contain the correct medication concentration.
“Imprimis Epinephrine-Lidocaine Vials Recalled Due to Assay Inaccuracy.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32742-imprimis-epinephrine-lidocaine-vials-recalled-due-to-assay-inaccuracy. Based on FDA recall #D-0478-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0478-2024%22&limit=1).
The FDA announced on April 10, 2024, that Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine HCl vials due to out-of-specification assay results. Owners should contact the company for a refund.
How to tell if you have it
Brand: Imprimis NJOF
Product: Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials
NDC: 71384-640-01
Lot codes: 23JUL028 (Exp. Date 8/1/2024), 23AUG053 (Exp. Date 8/30/2024)
Units affected: 15,414
The hazard
The recall is due to the product being out of specification for assay. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Imprimis NJOF, LLC has 13 other recalls on record since 2020-12-17. Other recent recalls of similar products include Imprimis NJOF recalls intraocular injection with glass particles (2025-12-18), Klarity-C Drops Recall: Subpotent Drug Risk (2025-10-20), and Imprimis Epinephrine Vials Recall: Subpotent Drug Risk (2025-07-09).
How to tell if you have this one
Check the vial label for the product name 'Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials'. Look for lot numbers 23JUL028 (expires 8/1/2024) or 23AUG053 (expires 8/30/2024).
Brand
Imprimis NJOF
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Label
Look for the lot numbers 23JUL028 or 23AUG053 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates the vials may not have the correct medication concentration, so they should not be used until the manufacturer provides instructions.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0478-2024 (April 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0478-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.