Why it was recalled
CGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Where it was sold
MO
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0200-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 17, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 858 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Park Avenue Compounding
Original FDA data
Every field from FDA enforcement report D-0200-2026, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 97960
- Address
- 3662 Park Ave Ste 140
- Code information
- Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
- Postal code
- 63110-2512
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0200-2026
- Classification
- Class II
- Recalling firm
- Park Avenue Compounding
- Product quantity
- 858 syringes
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- MO
- Recall initiation date
- Sep 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2025