Phenyephrine recalls

The FDA has published 3 recalls involving Phenyephrine since 2019. The latest was reported on 9 Oct 2019. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 9 Oct 2019

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

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

Why phenyephrine is recalled

Sterility3100%

Companies

KRS Global Biotechnology3100%

By year

20193100%

All phenyephrine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019Drug	CLASS II	PHENYephrine HCl in 0.9% Sodium Chloride (PF) recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites) recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	PHENYephrine HCl in 0.9% Sodium Chloride (PF) recalled	KRS Global Biotechnology	Sterility	Nationwide

Should you stop taking Phenyephrine?

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.