Warning
Park Avenue Compounding Recalls Phenylephrine HCI
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0200-2026Drug / Pharmaceutical
Park Avenue Compounding Recalls Phenylephrine HCI
Park Avenue Compounding · Class II — Moderate Risk
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.
Reason for Recall
CGMP Deviations
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
MO
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Park Avenue Compounding has recalled a pharmaceutical product that the FDA classified as Class II affecting 858 syringes. The recall was initiated on September 17, 2025. CGMP Deviations. It was distributed in MO. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.