Saturday, January 7, 2012

FDA Recalls Fluzone Vaccine Jan 4, 2012

The U.S. Food and Drug Administration posted a recall on January 4th, 2012 for Fluzone vaccines.

Here is the recall page.

In case you cannot view the information, here are the details:

Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5 mL, NDC 49281-011-10. Recall # B-0460-12

Lot numbers U4114DA, exp 6/30/12; U4118AA, exp 6/30/12; U4118BA, exp 6/30/12; U4118BB, exp 6/30/12; U4122AA, exp 6/30/12; U4122BA, exp 6/30/12; U4122CA, exp 6/30/12; U4124AA, exp 6/30/12; U4124BA, exp 6/30/12; U4124CA, exp 6/30/12; U4147AA, exp 6/30/12; U4147BA, exp 6/30/12; U4147CA, exp 6/30/12; U4149AA, exp 6/30/12; U4159DA, exp 6/30/12; U4178AA, exp 6/30/12; U4178BA, exp 6/30/12; U4184AA, exp 6/30/12; and U4197AB, exp 6/30/12

Sanofi Pasteur, Inc., Swiftwater, PA, by letter on November 14, 2011. Firm initiated recall is ongoing.

Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5mL, misbranded due to an error in the Prescribing Information (PI) included in packages of 10 single-dose vials of Fluzone vaccine, was distributed.

2,832,810 units


Fluzone is an inactivated, injected vaccine. It is the only vaccine on the market approved for ages 6 months and older. Here is the pamphlet insert from the manufacturer.

As of today, searching on does not seem to bring up any articles related to this recall. If anyone has additional information on the nature of this recall, please share with us in the comments.

This is a good time for me to reiterate my reminder: ALWAYS get the Lot #, expiration date and any other paperwork, packaging or labels you can get your hands on at the doctor's office. Watch the doctor or nurse remove the vaccine from the box to ensure it is the right vaccine. Take home all the paperwork and packaging and file it under your child's health records along with any insurance paperwork.

Related Resources

Pro-vaccine links

Where to Begin


  1. the recall is on the insert wording not the vaccine. I had my doctor look into it for me.

  2. Thanks for your post. I saw it and gave my pediatrician's office a call. Turns out it was really just a notice of a reprint for a transcription error in the package insert that has no effect on the vaccine or dosing instructions at all.

    I posted about it over on my blog here: