FDA Recall D-0200-2026
Park Avenue Compounding · Saint Louis, MO
Class II Ongoing 239 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0200-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- MO
- Recall initiated
- 2025-09-17
- Classified by FDA Center
- 2025-12-02
- FDA published
- 2025-12-10
- Recalling firm
- Park Avenue Compounding
- Firm location
- Saint Louis, MO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.