The Recall Desk
HighFDA (Drugs)·D-0200-2026·Announced 2025-12-10

[pending] Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park

Pending LLM rewrite. Source: FDA_DRUG D-0200-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

CGMP Deviations

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

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