Phenylephrine HCl 0 — Class II drug recall D-0014-2025
Terminated recall by Fresenius Kabi Compounding, LLC, reported 2024-10-30, distributed nationwide. CGMP violations
| Recall number | D-0014-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi Compounding, LLC, Canton, MA, United States |
| Recall initiated | 2024-09-25 |
| Classified | 2024-10-21 |
| Reported by FDA | 2024-10-30 |
| Terminated | 2025-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,313 bags |
| Reason classes | cgmp |
| NDC | 71506-0002-58 |
| Lot numbers | C274-000039006 |
| Expiration dates | 2025-01-19 |
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Reason for recall
CGMP violations
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-0014-2025. 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.