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
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
- Brand
- Genestra AFA-gen
- 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 2018 | Recall initiated by company | |
| 6 Aug 2018 | Classified by FDA | +10 days |
| 15 Aug 2018 | Published 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).
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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