Phenylephrine Hci recalls

The FDA has published 3 recalls involving Phenylephrine Hci since 2016. The latest was reported on 10 Dec 2025. Most were for sterility. Park Avenue Compounding has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2016

Last 12 months1reported

Class I00% of total

Ongoing1latest 10 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 1 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why phenylephrine hci is recalled

Sterility267%
Manufacturing (CGMP) Deviations133%

Companies

By year

2025133%
2016267%

Ongoing phenylephrine hci recalls

1 active

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Phenylephrine HCI, 1000 mcg / Total Volume recalled	Park Avenue Compounding	Manufacturing (CGMP) Deviations	MO

All phenylephrine hci recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Phenylephrine HCI, 1000 mcg / Total Volume recalled	Park Avenue Compounding	Manufacturing (CGMP) Deviations	MO
28 Sep 2016Drug	CLASS II	Phenylephrine HCI Injection, USP, 10mg/mL recalled by Sandoz	Sandoz	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Phenylephrine HCI 40mg/ in 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide

Should you stop taking Phenylephrine Hci?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.