RecallHawk
Class I Recall

Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor

Orgain

Summary

The FDA issued a Class I for Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor by Orgain. Reason: Undeclared allergen; sesame.

Details

Source

Food Recall

External ID

F-0302-2024

Action Date

2023-11-01

Status

Terminated

Category

food

Product Description

Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor

Lot/Code Info: Lot Code 3212 EL 14 (Mfr Date 7/31/2023, Best Before Date 7/31/2025); Lot Code 3213 EL 1414 (Mfr Date 8/1/2023, Best Before Date 8/1/2025), Lot Code 3214 EL 14 (Mfr Date 8/2/2023, Best Before Date 8/2/2025), Lot Code 3228 EL 14 (Mfr Date 8/16/2023,, Best Before Date 8/16/2025)

Quantity Affected: 54,546 Jars

Reason for Recall

Undeclared allergen; sesame

Distribution

U.S. distribution to Costco stores in the following states and territories: AK, AL, CA, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, VA, VT, WA, WI. No foreign distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-09-28

Company

Orgain

Irvine, CA

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 16 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orgain) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Orgain have FDA actions?

This is the only FDA action we have on record for Orgain in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0302-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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