CLASS III Drug recall · Reported 22 Jun 2016 · FDA Enforcement Report
Hectorol (doxercalciferol injection) 2 mcg recalled
Genzyme Corporation / Genzyme Biosurgery is recalling Hectorol (doxercalciferol injection) 2 mcg, distributed in Michigan, New Jersey, Pennsylvania. The recall was initiated on 27 Apr 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1029-2016
- FDA event ID
- 74046
- Recalling firm
- Genzyme Corporation / Genzyme Biosurgery, Ridgefield, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Apr 2016
- FDA classified
- 10 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Apr 2016 | Recall initiated by company | |
| 10 Jun 2016 | Classified by FDA | +44 days |
| 22 Jun 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Product as listed by the FDA
Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
Where it was distributed
MI, PA & NJ
Questions about this recall
Why was it recalled?
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Which lots are affected?
Lot #: 6R1001, Exp. 12/2016
Where was it sold?
MI, PA & NJ
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Genzyme Corporation / Genzyme Biosurgery
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mozobil (plerixafor injection) 24 mg/ (20 mg/mL) per vial recalledMozobil | Genzyme Corporation / Genzyme Biosurgery | Other | Nationwide |