June 1, 2013
September 4, 2015
Clinical Nutrition Services
Formula and Donor Human Milk Recall
To provide guidelines for when a formula or donor human milk recall occurs that will ensure
safety in the hospital and outpatient setting.
The handling of a formula or donor human milk recall will be the responsibility of the Clinical
Nutrition Department and Milk Lab personnel.
1. The clinical nutrition director will notify the appropriate clinical nutrition, medical,
nursing, and administrative personnel at University of Wisconsin Hospital and Clinics
when a recall occurs.
2. Formula Guidelines:
1. Infant Formula must be removed from the market when evidence of
adulteration or misbranding of the formula has been determined by the FDA.
Formula recalls will either by voluntary through the manufacturer or a regulatory
2. When a formula recall is initiated, obtain the list of batch numbers provided by
3. Milk lab technicians will survey current supply in the Milk Lab, unit stock, and
samples in the specialty clinics at American Family Children’s Hospital.
1. Patient’s that receive samples through the specialty clinics will include
the following documentation:
1. Patient’s name
2. Medical record number
3. Product name
4. Batch number and expiration date of all samples provided
1. Discard any unused formula per manufacture’s or regulatory agency’s instructions.
1. Donor Human Milk Guidelines:
1. In the event of a donor human milk recall, the director of the milk bank will
notify the hospital.
2. The Milk Lab technician will isolate all the bottles affected by the recall.
1. Do not destroy any bottles until the milk bank director advises.
3. Document the status of all bottles affected on the Donor Human Milk Recall log,
including those that have already been given to patients.
4. Fax a copy of the Donor Human Milk Recall Low to the HMBANA milk bank once
complete list obtained.
1. For those patients affected by the recall, notify the patient’s medical team and family.
2. Document a list of those affected with actions taken and any adverse side effects that
may have occurred.
3. Keep all recall related forms in the Milk Lab and file appropriately for future reference.
Director, Culinary and Clinical Nutrition Services
Associate Chief Nursing Officer and VP Development, Nursing & Patient Care Services