fentaNYL Citrate Injection — Class II drug recall D-0034-2017
Terminated recall by Pharmedium Services, LLC, reported 2016-10-19, distributed nationwide. Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency
| Recall number | D-0034-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2015-07-17 |
| Classified | 2016-10-12 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-06-23 |
| Distributed | Nationwide (US) |
| Quantity | 4,347 syringes |
| Reason classes | potency, specification failure |
| Lot numbers | 15100052M, 15103048M, 15104052M, 15118032M, 15127009M, 15127068M, 15134039M, 15135009M, 15135054M, 15140070M, 15147039M, 15148065M, 151900145M, 151930043M |
Product
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
Reason for recall
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
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-0034-2017. 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.