Hectorol — Class III drug recall D-1029-2016
Terminated recall by Genzyme Corporation / Genzyme Biosurgery, reported 2016-06-22, distributed in MI, NJ, PA. Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
| Recall number | D-1029-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genzyme Corporation / Genzyme Biosurgery, Ridgefield, NJ, United States |
| Recall initiated | 2016-04-27 |
| Classified | 2016-06-10 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-06-23 |
| Distributed | MI, NJ, PA |
| Quantity | 2,350 vials |
| Reason classes | labeling |
| NDC | 58468-0126-01 |
| Lot numbers | 6R1001 |
| Expiration dates | 2016-12 |
Product
Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
Reason for recall
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1029-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.