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Mead Johnson Nutrition
FDA recall F-2170-2015 · Class II · reported 2015-05-13 · Terminated
- Product
- Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case
- Reason
- Some Pregestimil 20 Calorie Nursette Bottles from batch EV5A6F were inadvertently packaged in Pregestimil 24 Calorie Nursette cartons. The individual Nursette bottles are correctly labeled as 20 Calorie. The carton is the cardboard sleeve wrapped around 6 bottles, the bottle labels and the outer corrugated case all correctly state 20 calorie.
- Quantity
- 235 cases
- Distribution
- Domestic: AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MS, NC, NE, NH, OH, OK, PA, SD, TX, UT, VA, WI, WV, Foreign: None
- Firm location
- IN, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Visit
- Recall started
- 2015-03-26
- Terminated
- 2015-10-27
- Code info
- Batch # EV5A6F
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.