Phenylephrine HCI recalled over manufacturing violations
- Recall date
- September 17, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Park Avenue Compounding recalls Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis,…
- Recall number
- D-0200-2026
- FDA classification
- Class II
- Brand / firm
- Park Avenue Compounding
- Sold / distributed
- MO
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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