Methylcobalamin recalls

The FDA has published 70 recalls involving Methylcobalamin since 2012. The latest was reported on 2 Jul 2025. Most were for sterility. Kalman Health & Wellness 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 recalls70since 2012

Last 12 months0reported

Class I00% of total

Ongoing6latest 2 Jul 2025

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 70 100%Class III 0 0%

Why methylcobalamin is recalled

Sterility6694%
Other Reasons46%

Companies

By year

202511%
202334%
202246%
2021710%
202023%
201969%
201857%
201746%
201646%
20151826%

Ongoing methylcobalamin recalls

6 active

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Methylcobalamin Injectable, 10mg/mL, pre-filled syringe recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methylcobalamin 10mg/mL, a)-vial, b)-vial, c)-vial recalled	TMC Acquisition	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL. recalled	Tri-Coast Pharmacy	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide

All methylcobalamin recalls, newest first

70 total

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Methylcobalamin Injectable, 10mg/mL, pre-filled syringe recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
1 Feb 2023Drug	CLASS II	Methylcobalamin 1MG/ML vial) recalled by Pharmacy Innovations	Pharmacy Innovations	Sterility	Nationwide
1 Feb 2023Drug	CLASS II	Methylcobalamin 12.5mg/ML Vial) Injectable Methylcobalamin recalled	Pharmacy Innovations	Sterility	Nationwide
18 Jan 2023Drug	CLASS II	Methylcobalamin Injection Solution, 12.5mg/ml recalled	Northern VA Compounders Pllc	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methylcobalamin 10mg/mL, a)-vial, b)-vial, c)-vial recalled	TMC Acquisition	Sterility	Nationwide
1 Jun 2022Drug	CLASS II	Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose vial recalled	Olympia Compounding Pharmacy	Sterility	Nationwide
23 Mar 2022Drug	CLASS II	Methylcobalamin 1 mg/mL Injectable in syringes recalled	Family Pharmacy of Statesville	Sterility	NC
22 Dec 2021Drug	CLASS II	Methylcobalamin 12mg/ml injection vials recalled by Valgene Incorporated	Valgene	Other	MD
8 Dec 2021Drug	CLASS II	Methylcobalamin Solution for Injection recalled by Asp Cares	ASP Cares	Sterility	TX
17 Nov 2021Drug	CLASS II	Methylcobalamin 5mg/ML (5000mcg/ML) Inj 5mg/ML Injectable recalled	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Methylcobalamin 1mg/ML (1000mcg/ML) Inj 1mg/ML Injectable recalled	Vita Pharmacy	Sterility	DC, PR
3 Nov 2021Drug	CLASS II	Methylcobalamin 12.5mg/ML Mdv Inj Soln recalled	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Methylcobalamin 5000mcg/ML Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states
3 Nov 2021Drug	CLASS II	Methylcobalamin 1000mcg/ML Mdv Inj recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	7 states
11 Mar 2020Drug	CLASS II	Methylcobalamin Injection, Methylcobalamin 1 MG/ML recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Methylcobalamin Injection, Methylcobalamin [CD] recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Methylcobalamin 1 MG/ML (Mdv) Injectable Solution per vial recalled	RXQ Compounding	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Methylcobalamin 10MG/ML Injectable Solution (Mdv) per vial recalled	RXQ Compounding	Sterility	Nationwide
17 Jul 2019Drug	CLASS II	Methylcobalamin 1 mg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019Drug	CLASS II	Methylcobalamin 10 mg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
24 Apr 2019Drug	CLASS II	Methylcobalamin 1 mg/mL Injection Vial recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
24 Apr 2019Drug	CLASS II	Methylcobalamin 3000 mcg/mL Injection Solution Vial recalled	Anderson Compounding Pharmacy	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Methylcobalamin 1 mg/mL a) Injectable recalled by Pharm D Solutions	Pharm D Solutions	Sterility	Nationwide
15 Aug 2018Drug	CLASS II	Methylcobalamin 1000 mcg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
25 Jul 2018Drug	CLASS II	Methylcobalamin 1mg/mL Injection w/Pres recalled	La Vita Compounding Pharmacy	Sterility	CA
16 May 2018Drug	CLASS II	Methylcobalamin for injection, 1mg/mL and 10 mg/mL recalled	Vitalab Pharmacy	Sterility	Nationwide
25 Apr 2018Drug	CLASS II	Methylcobalamin 12.5 mg/mL, Injectable Liquid recalled	Partell Specialty Pharmacy	Sterility	NV
20 Sep 2017Drug	CLASS II	Methylcobalamin 10mg, (1mg/ml) vials recalled by Bella Pharmaceuticals	Bella Pharmaceuticals	Sterility	Nationwide
20 Sep 2017Drug	CLASS II	Methylcobalamin 10mg, (10mg/ml) vials recalled by Bella Pharmaceuticals	Bella Pharmaceuticals	Sterility	Nationwide

Should you stop taking Methylcobalamin?

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.