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Natures Bounty Inc Recall: High level of microcystin observed in the product.

United States

TerminatedClass II

Company
Natures Bounty Inc
Product
BLUE GREEN ALGAE: Packaged under the following brands: AMERI…
Recall date
August 7, 2018
Terminated
March 20, 2019
Source
FDA

Reason for recall

High level of microcystin observed in the product.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
BLUE GREEN ALGAE: Packaged under the following brands: AMERICAN HEALTH KALMATH SHORES BLUE GREEN ALGAE, 120 CAPSULES, UPC: 0 76630 02542 3 and Puritan's Pride PREMIUM Kalamath Lake Blue Green Algae, 500 MG, 120 RAPID RELEASE CAPSULES, UPC 0 74312 12542 3 Not published in this source record 71,409 Bottles Lot Number/Expiry Date: 178747 / 05/2020;199658 / 10/2020; 264855 / 04/2021; 33766 / 01/2020; 959219 / 02/2019; 964323 / 10/2018; 982016 / 04/2019; 982017 / 05/2019

Distribution

  • Nationwide and Foreign: AUSTRALIA AUSTRIA BELGIUM CANADA CANADA CHILE CHINA COLOMBIA CROATIA DOMINICAN REPUBLIC ECUADOR ENGLAND FINLAND FRENCH POLYNESIA TAHITI GUATEMALA HONG KONG HUNGARY ICELAND ISRAEL ITALY JAMAICA JAPAN KAZAKHSTAN MACEDONIA MALAYSIA MEXICO MOLDOVA NETHERLANDS NEW ZEALAND PARAGUAY POLAND ROMANIA SCOTLAND SOUTH AFRICA SOUTH KOREA(ROK) SPAIN SWITZERLAND SWITZERLAND TAIWAN U.S.A. UGANDA VANUATU

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1835-2018
Event ID
80781
Status
Terminated
Classification
Class II
Company
Natures Bounty Inc
Product description
BLUE GREEN ALGAE: Packaged under the following brands: AMERICAN HEALTH KALMATH SHORES BLUE GREEN ALGAE, 120 CAPSULES, UPC: 0 76630 02542 3 and Puritan's Pride PREMIUM Kalamath Lake Blue Green Algae, 500 MG, 120 RAPID RELEASE CAPSULES, UPC 0 74312 12542 3
Quantity
71,409 Bottles
Reason
High level of microcystin observed in the product.
Recall initiation date
August 7, 2018
Report date
August 29, 2018
Classification date
Not published in this source record
Termination date
March 20, 2019
Distribution pattern
Nationwide and Foreign: AUSTRALIA AUSTRIA BELGIUM CANADA CANADA CHILE CHINA COLOMBIA CROATIA DOMINICAN REPUBLIC ECUADOR ENGLAND FINLAND FRENCH POLYNESIA TAHITI GUATEMALA HONG KONG HUNGARY ICELAND ISRAEL ITALY JAMAICA JAPAN KAZAKHSTAN MACEDONIA MALAYSIA MEXICO MOLDOVA NETHERLANDS NEW ZEALAND PARAGUAY POLAND ROMANIA SCOTLAND SOUTH AFRICA SOUTH KOREA(ROK) SPAIN SWITZERLAND SWITZERLAND TAIWAN U.S.A. UGANDA VANUATU
UPC, lot, and code information
Lot Number/Expiry Date: 178747 / 05/2020;199658 / 10/2020; 264855 / 04/2021; 33766 / 01/2020; 959219 / 02/2019; 964323 / 10/2018; 982016 / 04/2019; 982017 / 05/2019
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Natures Bounty Inc

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.