The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-0810-2023·Announced 2023-05-10

Dietary Supplement Protein Bottles Recalled for Bloated Packaging

Novis PR is recalling GPre Protein dietary supplement (lot 230118) due to bloated bottles affecting 6,034 units distributed domestically.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Bloated bottles in a liquid dietary supplement may indicate contamination risk. Although no illnesses have been reported, this Class II recall warrants High severity based on risk-of-harm criteria.

Plain-English summary

GPre Protein is a liquid predigested protein dietary supplement manufactured by Novis PR, LLC (dba Kramer Novis). The product is being recalled due to bloated bottles.

The recalled product is GPre Protein, 16 oz plastic bottles, lot number 230118 (UPC 52083633164). Approximately 6,034 units were distributed domestically.

Bloated bottles have been identified in this recall. For more information, refer to FDA recall number F-0810-2023.

The recalled product

Product
GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 case.
Affected units
6,034

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)

  • lot 230118 UPC Code: 52083633164

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Novis PR, LLC dba Kramer Novis under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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