Safety Alerts & Recalls

What does this mean?

This recall for Lantus (insulin glargine [rDNA origin] injection) 10 mL was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. However, since these recalled vials may not be sterile, you should check your vials to see if they are labeled with the lot numbers A1259, A1271, or A1295. If you have vials labeled with these recalled lot numbers, please return them to your pharmacy to examine and possibly exchange. If you have any concerns about this alert, your insulin, or any of your medicines, you should speak to your doctor.

Healthcare providers and patients are encouraged to report side effects or problems related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Sanofi-aventis US, Inc. Recalls Several Lots of Lantus

Sanofi-aventis US, Inc. has recalled several lots of Lantus (insulin glargine [rDNA origin] injection) 10 mL. The following lot numbers have been recalled because the vials in these lots may not be sterile: A1259, A1271, and A1295.

Lantus contains the active ingredient insulin glargine and is commonly used in the treatment of diabetes. This recall alert only applies to the select lots of Lantus (insulin glargine [rDNA origin] injection) 10 mL from the 3 lots listed above. No other Lantus products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2012-02-02
Last Updated: 2012-02-02

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