Epinephrine Injection — Class II drug recall D-1421-2012
Terminated recall by Luitpold Pharmaceuticals, Inc., reported 2012-07-25, distributed nationwide. Presence of Particulate Matter
| Recall number | D-1421-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luitpold Pharmaceuticals, Inc., Shirley, NY, United States |
| Recall initiated | 2012-04-24 |
| Classified | 2012-07-16 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2017-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 63,750 ampules |
| Reason classes | specification failure |
| NDC | 00517-1071-25 |
| Lot numbers | 1395 |
| Expiration dates | 2012-07-20 |
Product
Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25
Reason for recall
Presence of Particulate Matter
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1421-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.