Sanofi-Aventis U.s. Mozobil Recall: FDA Class III

Why it was recalled

Labeling: Incorrect or Missing Package Insert

Product description

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

Lot numbers, UPCs & expiration codes

Lot #: 5RZ001C, 5RZ001D; Exp. 04/18

Where it was sold

Nattionwide

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-0704-2017
Classification: Class III
Status: Terminated
Recall initiated: Sep 1, 2016
FDA report date: May 17, 2017
Quantity: 2133 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Sanofi-Aventis U.S. LLC

Original FDA data

Every field from FDA enforcement report D-0704-2017, exactly as published.

Show all FDA fields

City: Bridgewater
State: NJ
Status: Terminated
Country: United States
Event ID: 76896
Address: 55 Corporate Dr
Code information: Lot #: 5RZ001C, 5RZ001D; Exp. 04/18
Postal code: 08807-1265
Report date: May 17, 2017
Product type: Drugs
Recall number: D-0704-2017
Classification: Class III
Recalling firm: Sanofi-Aventis U.S. LLC
Product quantity: 2133 vials
Termination date: Feb 15, 2018
Reason for recall: Labeling: Incorrect or Missing Package Insert
Voluntary / mandated: Voluntary: Firm initiated
Product description: Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01
Distribution pattern: Nattionwide
Recall initiation date: Sep 1, 2016
Initial firm notification: Letter
Center classification date: May 11, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0704-2017, published May 17, 2017. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Sanofi-Aventis U.S. Mozobil Recall

Summary