Fentanyl 500mcg — Class II drug recall D-0487-2023
Ongoing recall by Apollo Care, reported 2023-04-05, distributed in MO. Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
| Recall number | D-0487-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apollo Care, Columbia, MO, United States |
| Recall initiated | 2023-02-08 |
| Classified | 2023-03-24 |
| Reported by FDA | 2023-04-05 |
| Distributed | MO |
| Quantity | 215 bags |
| Reason classes | microbial contamination, labeling, sterility |
| NDC | 71170-0950-25 |
| Lot numbers | AC-016581 |
Product
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason for recall
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
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-0487-2023. 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.