In 2022, Lyon Magnus LLC issued a voluntary recall for over 53 nutritional and beverage products, including plant-based milks, protein shakes, and coffee drinks, due to the failure of these products to meet commercial sterility specifications, with a consequent risk of microbial contamination with organisms such as Cronobacter sakazakii and Clostridium botulinum. It turns out that the issue arose from package defects that compromised the product sterility. [1]

Lyons Magnus Recall (2022)-Packaging Failures in RTD Plant-Based Beverages Leading to Shelf Recalls

Recall , April 19, 2025

In 2022, Lyon Magnus LLC issued a voluntary recall for over 53 nutritional and beverage products, including plant-based milks, protein shakes, and coffee drinks, due to the failure of these products to meet commercial sterility specifications, with a consequent risk of microbial contamination with organisms such as Cronobacter sakazakii and Clostridium botulinum. It turns out that the issue arose from package defects that compromised the product sterility. [1]

Purpose of the Recall

The ready-to-drink plant-based beverages have undergone aseptic processing- a system that sterilizes the product and its packaging separately before filling into the packages. In this case, the failure of sterility validation and inadequate sealing integrity at high-speed production, compromised the packaging system. These may let microorganisms be introduced, especially in nutrient-rich matrices such as oat milk, protein shakes, and other nutritional drinks. These are usually touted as “shelf-stable”, but this makes them particularly prone to contamination after production when the sterility seal on their packaging fails. [2]

Root Cause: Packaging Failure

The recall was initiated after quality control investigations pointed toward the possibility of a risk for microbial contamination caused by failures in packaging. In essence, the products failed to address commercially sterile standards and created conditions for the growth of severe pathogens such as:

Cronobacter sakazakii
Clostridium botulinum

At that time, the company and the U.S. FDA acted quickly without any reports of illness. Root cause analysis points to the reason for this recall as the products failing commercial sterility specifications. [3]

Product Description

Brand(s): Lyons Magnus, Oatly, Premier Protein, Glucerna, Stumptown, MRE, etc.
Product: RTD plant-based and nutritional beverages
Format: Tetra Pak cartons, aseptic plastic bottles
Issue: Packaging failure leading to microbial contamination risk
Recall Classification: Class I and II, depending on product and pathogen risk
Lot Codes: Varied across brands
Best by dates: Ranged from 2022–2023 [4]

Issue Identified

Quality assurance flagged the packaging-related deviations during post-production sterility audits. Third-party microbial testing confirmed the presence of Cronobacter sakazakii and potential Clostridium botulinum, a rare but serious pathogen that could cause life-threatening botulism when present. Although no actual botulinum toxin was found, Class I Recall status was attributed to the failure of certain products to meet commercial sterility standards from the FDA. The product was recalled and customers warned within minutes due to potential health risks. [5]

Ends of Regulatory Concern

In addition to this, non-compliance is also a classic violation of 21 CFR Part 113 pertaining to low-acid canned food which iterates that low-acid foods ought to be thermally processed in hermetically sealed containers. It is, therefore, a crucial regulation for shelf-stable end-use ready-to-drinks.
FDA asserts that failure to validate aseptic packaging lines could pose conditions for devastating microbial survival in shelf-stable beverages.
Under the law called the Food Safety Modernization Act (or FSMA), manufacturers need to put risk-based preventive controls into practice, among which should be the validation of aseptic packaging systems this is a part of food safety plan.
This was the case that showed deficiencies in preventive controls, environmental monitoring, and end-product testing practices in contract packaging facilities.

Manufacturer’s Consumer Guidance

Lyons Magnus released a public advisory on its website. It also sent out FDA alerts on the issue, advising consumers to:

- Don’t use the affected products.
- Match product codes and “Best By” dates with those posted on the official recall list.
- Throw away the contaminated products or return them for a refund.
- If there are any adverse effects report it to the FDA’s MedWatch program.

The company confirmed that not all SKUs or batches were affected. Lyons committed themself to reinforce aseptic validation processes, improve audits of packaging lines and work with third-party quality assurance providers for compliance oversight. [6]

FRL Commentary

This event is a reminder that solid packaging validation is required in the plant-based RTD segment where sterility is the matter of the case. FRL suggests beverage companies:

Perform integrity testing on their packaging formats, especially Tetra Pak and aseptic bottles.

Add end-of-line microbial testing to routine QC.

Accelerated shelf-life studies and seal-strength testing should validate the packaging systems for contamination.

Conclusion

The Lyons Magnus recall exemplifies the urgent requirement of aseptic processing and the integrity of packaging in ready-to-drink plant-based beverages. Not only the illnesses reported but also the identified risks related to microbes emphasize compliance with 21 CFR Part 113 and the FSMA preventive controls. Sterility validation and provision of quality assurance for the manufacturers should happen proactively. Food Research Lab provides firms with state-of-the-art validation for packaging, microbial testing services, and regulatory compliance to guarantee the safety and shelf stability of products.