Hydroxocobalamin recalls

The FDA has published 5 recalls involving Hydroxocobalamin since 2013. The latest was reported on 11 Mar 2020. Most were for sterility. FVS Holdings 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 recalls5since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 11 Mar 2020

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 5 100%Class III 0 0%

Why hydroxocobalamin is recalled

Companies

By year

2020120%
2015360%
2013120%

All hydroxocobalamin recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020Drug	CLASS II	Hydroxocobalamin Injection, Hydroxocobalamin 5MG/ML recalled	Fusion IV Pharmaceuticals	Foreign Material	Nationwide
9 Dec 2015Drug	CLASS II	Hydroxocobalamin Injection, Rx recalled by Life Science Pharmacy	Life Science Pharmacy	Other	Nationwide
25 Nov 2015Drug	CLASS II	Hydroxocobalamin Injection (Buffered) 1mg/mL vial recalled	Downing Labs	Sterility	Nationwide
1 Apr 2015Drug	CLASS II	Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx recalled	American Specialty Pharmacy	Particulate Matter	TX
22 May 2013Drug	CLASS II	Hydroxocobalamin Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Hydroxocobalamin?

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.