PlainRecalls
ModerateClass IITerminated

FDA Food recall · Reported May 10, 2023

PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case

Bloated Protein Bottle

Recall #
F-0811-2023
Affected scope
4106 units
Initiated
March 27, 2023
Verify with FDA Food →
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Novis Pr, LLC dba Kramer Novis recalled PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 2… - a moderate-severity action.

PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 2… was recalled by Novis Pr, LLC dba Kramer Novis in May 10, 2023. Reason: Bloated Protein Bottle. Check the official notice for the remedy. Verify recall #F-0811-2023 with the FDA Food before acting.

The recall

Novis Pr, LLC dba Kramer Novis issued this moderate-severity FDA Food recall-Bloated Protein Bottle.

Moderate
severity level
4K units
affected scope
Class II
classification
May 10, 2023
reported

Sourced from official FDA Food enforcement records. Verify recall #F-0811-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case

Reason for recall

Bloated Protein Bottle

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number F-0811-2023
Date reported May 10, 2023
Date initiated March 27, 2023
Recalling firm Novis Pr, LLC dba Kramer Novis
Firm location San Juan, PR
Affected scope 4106 units
Distribution Domestic distribution only.

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

4106 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (F-0811-2023) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Food before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case. Recalled by Novis Pr, LLC dba Kramer Novis. Units affected: 4106 units.
Why was this product recalled?
Bloated Protein Bottle
Which agency issued this recall?
This recall was issued by the FDA Food on May 10, 2023. Severity: Moderate. Recall number: F-0811-2023.
Where was the recalled product distributed?
Distribution: Domestic distribution only..
What are the health risks of consuming a recalled food product?
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.

Nationwide recalls with similar severity or category timing

Food and dietary-supplement notices outside this firm and state, matched by severity timing and product category.

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Food, reported May 10, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026