FDA Drugs recall ·
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only… recall
- Recall number
- D-0200-2026
- Date
- (initiated September 17, 2025)
- Company / brand
- Park Avenue Compounding
3662 Park Ave Ste 140, Saint Louis, MO, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 858 syringes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Distribution
MO
States: Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0200-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.