Park Avenue Compounding 2025-12-10 Health serious FDA
Health · FDA · Recall #FDA-D-0200-2026
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue… Recall
Issued December 10, 2025 · Park Avenue Compounding
In December 2025, Park Avenue Compounding recalled the Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations
What you should do
- 1 Stop using Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Park Avenue Compounding to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Park Avenue Compounding
- Category
- Health
- Recall date
- December 10, 2025
- Units affected
- Not reported
- Sold at
- MO
- Recall number
- FDA-D-0200-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Park Avenue Compounding has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.