The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-1059-2013·Announced 2013-03-13

Herbalife Formula 1 Vanilla Dream Shake Mix Recalled for Undeclared Milk

Herbalife is recalling Formula 1 Vanilla Dream Shake Mix packets due to trace amounts of undeclared milk protein.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Herbalife of America Inc is initiating this recall due to trace amounts of an undeclared milk protein allergen."

Plain-English summary

Herbalife International of America Inc is recalling its Formula 1 Instant Healthy Meal, Nutritional Shake Mix (Vanilla Dream) packets. The product is sold in cardboard cartons containing 12 packets, as well as in IBP Kits. The recall involves 5,928 units, comprising 2,732 cartons and 3,196 IBP Kits, which were distributed worldwide.

The recall was initiated because the product contains trace amounts of an undeclared milk protein allergen. This mislabeling poses a risk to consumers with milk allergies who may consume the product without knowing it contains milk.

Consumers with milk allergies should avoid using the recalled product. The specific lot numbers affected are 133405G10, 133408G10, and 133409G10. The source text does not specify a consumer action such as returning the product or seeking a refund, nor does it report any illnesses or injuries associated with the recall.

The recalled product

Product
HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet;

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Herbalife International Of America Inc

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