RecallHawk
Class II Recall

Alpha Test 120 count Black labeled plastic bottle, 12 bottles per case of 120 count capsules each per bottle, Store in a

Iovate Health Sciences USA Inc.

Summary

The FDA issued a Class II for Alpha Test 120 count Black labeled plastic bottle, 12 bottles per case of 120 co by Iovate Health Sciences USA Inc.. Reason: Presence of cathine in product.

Details

Source

Food Recall

External ID

F-0455-2025

Action Date

2025-02-05

Status

Terminated

Category

food

Product Description

Alpha Test 120 count Black labeled plastic bottle, 12 bottles per case of 120 count capsules each per bottle, Store in a cool, dry place (60 F to 80 F), UPC 6-31656-60676-8, SKU0001191, SKU0002075

Lot/Code Info: Expiration Date and Lot Codes: March 21, 2027 (Lots 24A125, 24B059, 24B060) March 22, 2027 (Lot 24C112) July 3, 2027 (Lots 24F164, 24G112) July 4, 2027 (Lot 24E288) July 5, 2027 (Lots 24G243, 24H207)

Quantity Affected: Total 163,248 units

Reason for Recall

Presence of cathine in product

Distribution

Domestic and foreign distribution:NC, CA, TX, NJ, VA, NV, PA, IN, NY, CA, IL,MS, KY, MI,SC, WA, CT, FL, OH, WI, DE, LA, TN, MO, UT, KH, GA, KS, CO, IA, AZ, OR. Foreign distribution: ZA, PH, IS, KZ, AE

Type: Voluntary: Firm initiated

Recall Initiated: 2024-12-18

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 47 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

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 (Iovate Health Sciences USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Iovate Health Sciences USA Inc. have FDA actions?

This is the only FDA action we have on record for Iovate Health Sciences USA Inc. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0455-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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