Ephedrine recalls

The FDA has published 36 recalls involving Ephedrine since 2014. The latest was reported on 11 Oct 2023. Most were for sterility. Pharmedium Services 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 recalls36since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 11 Oct 2023

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 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 36 100%Class III 0 0%

Why ephedrine is recalled

Companies

By year

202338%
202213%
202138%
202026%
2019514%
2018719%
2017617%
2016822%
201413%

Ongoing ephedrine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Ephedrine Sulfate Injection recalled by Akorn	Akorn	Potency & Assay	Nationwide

All ephedrine recalls, newest first

36 total

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023Drug	CLASS II	ePHEDrine in 0.9% sodium chloride, 50 mg/, (10 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	ePHEDrine in 0.9% sodium chloride, 50 mg /, (10 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Ephedrine Sulfate Injection recalled by Akorn	Akorn	Potency & Assay	Nationwide
9 Feb 2022Drug	CLASS II	Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets recalled	Ultra Seal	Manufacturing (CGMP) Deviations	Nationwide
13 Jan 2021Drug	CLASS II	ePHEDrine Sulfate, 50 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
13 Jan 2021Drug	CLASS II	ePHEDrine 25 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
13 Jan 2021Drug	CLASS II	ePHEDrine Sulfate 50 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 50 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg recalled	KRS Global Biotechnology	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Ephedrine 5MG/ML (PF) Syringe per syringe, Rxq Compounding recalled	RXQ Compounding	Sterility	Nationwide
27 Feb 2019Drug	CLASS II	Ephedrine Sulfate, 50 mg/ Single Use Syringe recalled by US Compounding	US Compounding	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	ePHEDrine 50mg, 50 mg/ (5 mg per mL) (Ephedrine Sulfate recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	ePHEDrine Sulfate, USP 50mg recalled by Avella of Deer Valley, Inc.	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Ephedrine Sulfate Injection in all strengths, all doses recalled	Pharmedium Services	Sterility	Nationwide
24 Jan 2018Drug	CLASS II	ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL recalled	Pharmedium Services	Potency & Assay	Nationwide
17 Jan 2018Drug	CLASS II	Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Other	Nationwide
1 Nov 2017Drug	CLASS II	ePHEDrine sulfate 50 mg/ syringes in 0.9% Sodium Chloride recalled	Banner Pharmacy Services	Sterility	Nationwide
16 Aug 2017Drug	CLASS II	Ephedrine Sulfate in 0.9% Sodium Chloride, 50 mg recalled	Cantrell Drug	Sterility	Nationwide
16 Aug 2017Drug	CLASS II	Ephedrine Sulfate Injection Solution, 50 mg recalled by Cantrell Drug	Cantrell Drug	Sterility	Nationwide
16 Aug 2017Drug	CLASS II	Ephedrine Sulfate in 0.9% Sodium Chloride, 25 mg recalled	Cantrell Drug	Sterility	Nationwide
16 Aug 2017Drug	CLASS II	Ephedrine Sulfate in 0.9% Sodium Chloride, 50 mg recalled	Cantrell Drug	Sterility	Nationwide
2 Aug 2017Drug	CLASS II	ePHEDrine Sulfate 5 mg/mL in NS Fill in Syringe (25 mg) recalled	SCA Pharmaceuticals	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride recalled	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016Drug	CLASS II	ePHEDrine Sulfate, 10 mg per mL, 50 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide
19 Oct 2016Drug	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide

Should you stop taking Ephedrine?

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.