Recall notice · FDA Recall Press Releases

Kiriko, LLC: FDA Recall Notice (Oct 19, 2017)

Agency action: Oct 19, 2017Record ID: fda_recall_p-869f0b5b66f1a4ca
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What happened

Original notice title

Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl Sibutramine

From the archived source record

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established; therefore, subject to recall. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. To date, Kiriko, LLC. has not received any reports of adverse events related to this recall. This tainted product is marketed as a weight loss dietary supplement and is packaged in a white plastic bottle containing 30 capsules with a white screw-on cap, barcode A105212014. The recall includes all lots of A1 Slim remaining within expiry. The product was distributed Nationwide via retail stores in Houston, TX and by mail-order (December 6, 2016-May 1, 2017).

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
Published recall notice
Source checked
Jul 16, 2026
Record revision
58ab51037102

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Dietary Supplement A1 Slim; in October 2010 due to safety concerns; TX and by mail-order (December 6; 2017)
Company
Kiriko, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.