FentaNYL 500mcg — Class II drug recall D-0409-2025
Ongoing recall by Apollo Care, LLC, reported 2025-05-14, distributed in MO. Lack of Assurance of Sterility
| Recall number | D-0409-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apollo Care, LLC, Columbia, MO, United States |
| Recall initiated | 2025-04-15 |
| Classified | 2025-05-06 |
| Reported by FDA | 2025-05-14 |
| Distributed | MO |
| Quantity | 440 bags |
| Reason classes | sterility |
| NDC | 71170-0950-25 |
| Lot numbers | AC-016878 |
| Expiration dates | 2025-06-16 |
Product
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
Reason for recall
Lack of Assurance of Sterility
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-0409-2025. 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.