Methionine recalls

The FDA has published 12 recalls involving Methionine since 2012. The latest was reported on 20 Jul 2022. Most were for sterility. TMC Acquisition 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 recalls12since 2012

Last 12 months0reported

Class I00% of total

Ongoing2latest 20 Jul 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 12 100%Class III 0 0%

Why methionine is recalled

Sterility12100%

Companies

By year

2022217%
202018%
2019217%
2018325%
2015325%
201218%

Ongoing methionine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methionine/Inositol/Choline B12 + Carnitine recalled by TMC Acquisition	TMC Acquisition	Sterility	Nationwide

All methionine recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methionine/Inositol/Choline B12 + Carnitine recalled by TMC Acquisition	TMC Acquisition	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Methionine/Inositol/Choline Injection recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Methionine 750 mg / Inositol 1,500 mg / Choline Chloride recalled	KRS Global Biotechnology	Sterility	Nationwide
24 Apr 2019Drug	CLASS II	Methionine 15mg/Choline 100mg/ Inositol 50mg recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
16 May 2018Drug	CLASS II	Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin recalled	Vitalab Pharmacy	Sterility	Nationwide
25 Apr 2018Drug	CLASS II	Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg amber vial recalled	Partell Specialty Pharmacy	Sterility	NV
25 Apr 2018Drug	CLASS II	Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg recalled	Partell Specialty Pharmacy	Sterility	NV
4 Nov 2015Drug	CLASS II	Methionine/Choline/Inositol, injectable Solution recalled by JD & SN Inc	JD & SN Inc	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml recalled	The Compounding Pharmacy of America	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Methionine / Inositol / Choline Chloride 25mg/75mg/75mg/ML recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Methionine?

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.