Severity
Moderate
FDA Drug recall · Reported November 8, 2017
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved …
Kiriko, LLC. recalled A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim L… - a moderate-severity action.
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim L… was recalled by Kiriko, LLC. in November 8, 2017. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, ph…. Check the official notice for the remedy. Verify recall #D-0058-2018 with the FDA Drug before acting.
The recall
Kiriko, LLC. issued this moderate-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, ph….
Sourced from official FDA Drug enforcement records. Verify recall #D-0058-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0058-2018) was formally reported on November 8, 2017, with the manufacturer initiating the action on October 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Kiriko, LLC. is listed as the recalling firm, operating out of Manvel, TX. Federal records list the affected scope as 700 bottles.
The documented reason for this recall is: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have … Distribution data in the federal record shows the product reached: Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
700 bottles
Related Recalls
6
5 from same agency
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0058-2018 |
| Date reported | November 8, 2017 |
| Date initiated | October 6, 2017 |
| Recalling firm | Kiriko, LLC. |
| Firm location | Manvel, TX |
| Affected scope | 700 bottles |
| Distribution | Nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Lupin Pharmaceuticals Inc. · 2026-05-27
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 8, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.