CLASS II Food recall · Reported 15 Aug 2018 · FDA Enforcement Report

Genestra AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue recalled

Seroyal International, a division of Atrium Innovations is recalling Genestra AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule, twice, distributed nationwide in the US. The recall was initiated on 27 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018
Quantity recalled4,226 bottles (1691 Canada and 2535 USA)

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number
F-1756-2018
FDA event ID
80661
Recalling firm
Seroyal International, a division of Atrium Innovations, Richmond Hill, Ontario
Classification
Class II
Status
Terminated
Recall initiated
27 Jul 2018
FDA classified
6 Aug 2018
Reported
15 Aug 2018
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons
Product category
Dietary Supplements

Timeline

27 Jul 2018Recall initiated by company
6 Aug 2018Classified by FDA+10 days
15 Aug 2018Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.

Product as listed by the FDA

Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White 150cc HDPE Bottle with Desiccant and white cap, packed as 12 bottles / shipper case

Where it was distributed

Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).

Nationwide

Questions about this recall

Why was it recalled?

Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.

Which lots are affected?

Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018

Where was it sold?

Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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