Cyanocobalamin recalls

The FDA has published 10 recalls involving Cyanocobalamin since 2013. The latest was reported on 26 Aug 2026. Most were for particulate matter. American Regent 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 months2reported

Class I00% of total

Ongoing2latest 26 Aug 2026

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 2 0

Severity split

Class I 0 0%Class II 8 80%Class III 2 20%

Why cyanocobalamin is recalled

Companies

By year

2026220%
2024110%
2022220%
2021110%
2020110%
2018110%
2014110%
2013110%

Ongoing cyanocobalamin recalls

2 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide

All cyanocobalamin recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
24 Jul 2024Drug	CLASS II	Cyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial recalled	Zydus Pharmaceuticals (USA)	Particulate Matter	TN
4 May 2022Drug	CLASS III	Cyanocobalamin Injection, USP, 1000 mcg per mL recalled	American Health Packaging	Potency & Assay	AL
20 Apr 2022Drug	CLASS III	Cyanocobalamin Injection, USP, 1,000 mcg per mL recalledCyanocobalamin	Aurobindo Pharma USA	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Cyanocobal Injection 1000MCG/ML 25X1ML recalled by Cardinal HealthCyanocobalamin	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
11 Mar 2020Drug	CLASS II	Cyanocobalamin Injection, Cyanocobalamin 2000 Mcg/ML recalled	Fusion IV Pharmaceuticals	Foreign Material	Nationwide
28 Feb 2018Drug	CLASS II	Cyanocobalamin USP (Vitamin B12) for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
17 Dec 2014Drug	CLASS II	Cyanocobalamin Injection, USP, 1000 mcg/mL recalledCyanocobalamin	Fresenius Kabi USA	Particulate Matter	Nationwide
22 May 2013Drug	CLASS II	Cyanocobalamin Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Cyanocobalamin?

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.