Cyanocobalamin recalls

The FDA has published 23 recalls involving Cyanocobalamin since 2013. The latest was reported on 26 Aug 2026. Most were for sterility. Aidapak Services 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 recalls23since 2013
Last 12 months2reported
Class I14% of total
Ongoing2latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 1 4%Class II 20 87%Class III 2 9%

By year

Ongoing cyanocobalamin recalls

2 active

All cyanocobalamin recalls, newest first

23 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IICyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalaminAmerican RegentParticulate MatterNationwide
DrugCLASS IICyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalaminAmerican RegentParticulate MatterNationwide
DrugCLASS IICyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial recalledZydus PharmaceuticalsParticulate MatterTN
DrugCLASS IICyanocobalamin 2 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
DrugCLASS IIICyanocobalamin Injection, USP, 1000 mcg per mL recalledAmerican Health PackagingPotency & AssayAL
DrugCLASS IIICyanocobalamin Injection, USP, 1,000 mcg per mL recalledCyanocobalaminAurobindo Pharma USAPotency & AssayNationwide
DrugCLASS IICyanocobal Injection 1000MCG/ML 25X1ML recalled by Cardinal HealthCyanocobalaminCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
DrugCLASS IICyanocobalamin Injection, Cyanocobalamin 2000 Mcg/ML recalledFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IICyanocobalamin/Folinic Acid Injection, Cyanocobalamin recalledFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IICyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol recalledIsomeric Pharmacy SolutionSterilityNationwide
DrugCLASS IICyanocobalamin 500 mcg/mL Injectable pre-filled syringe recalledLiberty Drug & SurgicalSterilityNJ, NY
DrugCLASS IICyanocobalamin 2000mcg/ Injection, Health Innov Pharmacy recalledHealth Innovations PharmacySterilityNC
DrugCLASS IICyanocobalamin Injection, USP, 1000 mcg/mL recalledCyanocobalaminFresenius Kabi USAParticulate MatterNationwide
DrugCLASS IICyanocobalamin 1000 mcg/mL injectable solution recalledMartin Avenue PharmacySterilityNationwide
DrugCLASS IICyanocobalamin 100mcg/ml injection recalled by Natures Pharmacy &Natures Pharmacy & Compounding CenterSterilityNC
DrugCLASS IICyanocobalamin, Tablet, 1000 mcg, Over The Counter recalledAidapak ServicesLabeling Errors4 states
DrugCLASS IICyanocobalamin, Tablet, 100 mcg, Over The Counter recalledAidapak ServicesLabeling Errors4 states
DrugCLASS IICyanocobalamin, Tablet, 500 mcg, Over The Counter recalledAidapak ServicesLabeling Errors4 states
DrugCLASS IICyanocobalamin, 1000 mcg/ml; injectable, all sizes recalledSpecialty Medicine Compounding PharmacySterilityMI
DrugCLASS IICyanocobalamin, Tablet, 1000 mcg, Over The Counter recalledAidapak ServicesLabeling Errors4 states
DrugCLASS IICyanocobalamin 1000 Mcg/ML Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
DrugCLASS IICyanocobalamin Injection, all strengths recalled by FVS HoldingsFVS HoldingsSterilityNationwide
DrugCLASS ICyanocobalamin 1000 mcg/ml, injection, MDV recalledGreen Valley DrugsSterilityNationwide

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.