Methylcobalamin recalls

The FDA has published 10 recalls involving Methylcobalamin since 2013. The latest was reported on 18 Jan 2023. Most were for sterility. Western Drug 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 recalls10since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Jan 2023

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 10 100%Class III 0 0%

Why methylcobalamin is recalled

Sterility880%
Foreign Material220%

Companies

By year

2023110%
2021110%
2020220%
2018110%
2015330%
2013220%

All methylcobalamin recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Drug	CLASS II	Methylcobalamin Injection Solution, 5mg/ml recalled	Northern VA Compounders P	Sterility	Nationwide
8 Dec 2021Drug	CLASS II	Methylcobalamin Solution for Injection recalled by Asp Cares	Asp Cares	Sterility	TX
11 Mar 2020Drug	CLASS II	Methylcobalamin Injection, Methylcobalamin 1 MG/ML recalled	Fusion IV Pharmaceuticals	Foreign Material	Nationwide
11 Mar 2020Drug	CLASS II	Methylcobalamin Injection, Methylcobalamin [CD] recalled	Fusion IV Pharmaceuticals	Foreign Material	Nationwide
16 May 2018Drug	CLASS II	Methylcobalamin for injection, 1mg/mL and 10 mg/mL recalled	Vitalab Pharmacy	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx recalled	Western Drug	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	Methylcobalamin Injection Buffered 5mg/mL vial recalled by Downing Labs	Downing Labs	Sterility	Nationwide
18 Sep 2013Drug	CLASS II	Methylcobalamin Injection 5 mg/mL recalled by South Coast Specialty	South Coast Specialty Compounding	Sterility	CA, IN
22 May 2013Drug	CLASS II	Methylcobalamin Injection, all strengths recalled by FVS Holdings	FVS Holdings	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.