Fentanyl citrate — Class II drug recall D-0178-2026
Ongoing recall by Park Avenue Compounding, reported 2025-11-26, distributed in MO. CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
| Recall number | D-0178-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Park Avenue Compounding, Saint Louis, MO, United States |
| Recall initiated | 2025-09-23 |
| Classified | 2025-11-20 |
| Reported by FDA | 2025-11-26 |
| Distributed | MO |
| Quantity | 189 bags |
| Reason classes | cgmp |
| NDC | 83863-4272-01 |
| Lot numbers | 20250507-01D93C |
| Expiration dates | 2025-11-04 |
Product
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
Reason for recall
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
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-0178-2026. 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.