ELCYS — Class I drug recall D-0118-2024
Ongoing recall by Exela Pharma Sciences LLC, reported 2023-11-29, distributed nationwide. Presence of Particulate Matter: Silicone
| Recall number | D-0118-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2023-10-18 |
| Classified | 2023-11-22 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 38,200 vials |
| Reason classes | specification failure |
| NDC | 51754-1007, 51754-1007-01, 51754-1007-03 |
| Lot numbers | 10000798 |
| Expiration dates | 2025-03-31 |
Product
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).
Reason for recall
Presence of Particulate Matter: Silicone
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-0118-2024. 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.