Phenylephrine HCI Syringes Recalled Due to Manufacturing Process Violations
Park Avenue Compounding is recalling 858 syringes of Phenylephrine HCI due to manufacturing deviations. The recall was voluntary and limited to Missouri.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing process deviations. Class II classification without reported hospitalizations or documented serious injuries indicates this is a high-risk-of-harm product without reported injury, warranting a High severity score (3) per the rubric.
Plain-English summary
Park Avenue Compounding initiated a voluntary recall of 858 syringes of Phenylephrine HCI (1000 mcg per 10 mL) following the discovery of Current Good Manufacturing Practice (CGMP) deviations during manufacturing. The affected lot is 20250813-13D65E, with an expiration date of February 9, 2026.
The recalled product was distributed in Missouri. Phenylephrine HCI is a prescription-only medication supplied in syringe form.
The recall was initiated by the manufacturer on September 17, 2025, and was classified as FDA Class II.
The recalled product
- 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.
- Manufacturer
- Park Avenue Compounding
- Category
- Drug — Injectable
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20250813-13D65E
- Exp Date: FEB-09-2026.
Distribution
Distributed in 1 state:
- MO
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