Genzyme Corporation / Genzyme Biosurgery Hectorol Recall

Why it was recalled

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

Product description

Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1

Lot numbers, UPCs & expiration codes

Lot #: 6R1001, Exp. 12/2016

Where it was sold

MI, PA & NJ

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1029-2016
Classification: Class III
Status: Terminated
Recall initiated: Apr 27, 2016
FDA report date: Jun 22, 2016
Quantity: 2350 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Genzyme Corporation / Genzyme Biosurgery

Original FDA data

Every field from FDA enforcement report D-1029-2016, exactly as published.

Show all FDA fields

City: Ridgefield
State: NJ
Status: Terminated
Country: United States
Event ID: 74046
Address: 1125 Pleasantview Ter
Code information: Lot #: 6R1001, Exp. 12/2016
Postal code: 07657-2310
Report date: Jun 22, 2016
Product type: Drugs
Recall number: D-1029-2016
Classification: Class III
Recalling firm: Genzyme Corporation / Genzyme Biosurgery
Product quantity: 2350 vials
Termination date: Jun 23, 2017
Reason for recall: Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
Distribution pattern: MI, PA & NJ
Recall initiation date: Apr 27, 2016
Initial firm notification: Letter
Center classification date: Jun 10, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1029-2016, published Jun 22, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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