Class IF-1650-2022

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

Tone It Up Plant-Based Protein Shake Chocolate. 11 fl oz (325mL). UPC 8 10745-03194 4. Sold in 4-count wrap UPC 810745031869. Shake Well. Serve Cold. Refrigerate after opening and use within 48 hours. Distributed by Tone It Up, Manhattan Beach, CA

Type: Food
Affected lot / code info: EXPANDED 8-10-2022 Lot Code 0321 / Best By Date 08/18/2022; Lot Code 1321 / Best By Date 08/19/2022.
Quantity: 53,818,025 total units

Why it was recalled

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Recalling firm

Firm: Lyons Magnus, Inc
Notification channel: Telephone
Type: Voluntary: Firm initiated
Address: 3158 E Hamilton Ave, Fresno, California 93702-4163

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-07-22
FDA classified: 2022-08-30
Posted by FDA: 2022-09-07
Terminated: 2024-07-25
Status: Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1650-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.