Phenylephrine HCI — Class II drug recall D-0200-2026
Ongoing recall by Park Avenue Compounding, reported 2025-12-10, distributed in MO. CGMP Deviations
| Recall number | D-0200-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Park Avenue Compounding, Saint Louis, MO, United States |
| Recall initiated | 2025-09-17 |
| Classified | 2025-12-02 |
| Reported by FDA | 2025-12-10 |
| Distributed | MO |
| Quantity | 858 syringes |
| Reason classes | cgmp |
| NDC | 83863-0104-01 |
| Lot numbers | 20250813-13D65E |
Product
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
Reason for recall
CGMP Deviations
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-0200-2026. 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.