Mead Johnson Recalls Pregestimil 20 Calorie Bottles Due to Carton Labeling Error
Mead Johnson Nutrition is recalling 235 cases of Pregestimil 20 Calorie Nursette bottles because some were packaged in 24 Calorie cartons. The bottles themselves are correctly labeled.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the bottles and outer cases are correctly labeled, limiting the hazard to a minor labeling error on the intermediate packaging.
Plain-English summary
Mead Johnson Nutrition is recalling 235 cases of Pregestimil ready to use 20 calorie, 2 oz bottles (batch # EV5A6F). The recall was initiated because some of these bottles were inadvertently packaged in Pregestimil 24 Calorie Nursette cartons.
The individual Nursette bottles, the bottle labels, and the outer corrugated cases are all correctly labeled as 20 calorie. The error is limited to the cardboard sleeve (carton) wrapped around the six bottles, which incorrectly identifies the contents as 24 calorie. The product was distributed in 30 US states including 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, and WV.
Consumers should check their inventory for batch # EV5A6F. If they have this product, they should stop using it and contact Mead Johnson Nutrition for further instructions or a refund, as the carton labeling does not match the product contents.
The recalled product
- Product
- Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case
- Manufacturer
- Mead Johnson Nutrition
- Category
- Food — Infant Formula
- Hazard
- Affected units
- 235
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch # EV5A6F
Distribution
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereMethocarbamol Tablets Mislabeled with Incorrect Strength
FDA (Drugs) · 2021-11-10
- LowRight Value Drug Stores Recalls Progesterone SR 200 mg Capsules for Misbranding
FDA (Drugs) · 2018-11-21
- SevereFDA Recalls Repacked Progesterone Capsules Due to Potential Labeling Error
FDA (Drugs) · 2014-01-29
- ModeratePepsiCo Recalls Diet Mountain Dew Bottles Mislabeled as Full Calorie
FDA (Food) · 2019-09-04
- SevereMass Nutraceuticals Brain Food Capsules Recall for Undeclared Milk
FDA (Food) · 2022-01-19
- LowBoehringer Ingelheim Roxane Recalls Prednisone Tablets Due to Missing Label
FDA (Drugs) · 2013-08-21