Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported May 10, 2023
PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case.
Bloated Protein Bottle
The recall
Novis Pr, LLC dba Kramer Novis issued this moderate-severity FDA Food recall — Bloated Protein Bottle.
- Moderate
- severity level
- 513 units
- affected scope
- Class II
- classification
- May 10, 2023
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0812-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0812-2023) was formally reported on May 10, 2023, with the manufacturer initiating the action on March 27, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Novis Pr, LLC dba Kramer Novis is listed as the recalling firm, operating out of San Juan, PR. Federal records list the affected scope as 513 units.
The documented reason for this recall is: Bloated Protein Bottle Distribution data in the federal record shows the product reached: Domestic distribution only.. Distribution scope 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, 6 from FDA Food — 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 — 3,146 children & baby products recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Affected scope
513 units
Related Recalls
6
6 from same agency
Product description
PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case.
Reason for recall
Bloated Protein Bottle
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0812-2023 |
| 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 | 513 units |
| Distribution | Domestic distribution only. |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0812-2023) 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. 16 oz Bottle, packed in 12 units of 16 oz. each per case.. Recalled by Novis Pr, LLC dba Kramer Novis. Units affected: 513 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-0812-2023.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0812-2023) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported May 10, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.