Food recall

NOW Foods recall: Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules

NOW Foods, of Bloomingdale, IL, recalled Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules and 4 other products. The FDA's reason: “Undeclared soy lecithin in 5 dietary supplements.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on March 18, 2016, and the FDA first listed it in its Enforcement Report of May 4, 2016. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Allergen not on the label

Status

Terminated

Closed July 21, 2017

The recall

Company
NOW Foods (Bloomingdale, IL)
Reason, in FDA's words
“Undeclared soy lecithin in 5 dietary supplements.”
Where it was sold
Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
73695

The 5 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1129-2016 Class II

    Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.

    Codes: Lot# 1966914, Batch# 582660

    Quantity: 8 bottles

  • F-1130-2016 Class II

    Elderberry 500 mg packaged in a white and orange bottle containing 60 capsules. The bottle has a blue cap and white lettering.

    Codes: Lot# 1966914, Batch# 582660

    Quantity: 57 bottles

  • F-1131-2016 Class II

    Gingko Biloba 60mg packaged in a white and orange bottle containing 120 capsules. The bottle has a blue cap and white lettering.

    Codes: Lot# 1969778, Batch# 582552

    Quantity: 2 bottles

  • F-1132-2016 Class II

    Goldenseal Root 500 mg packaged in a white and orange bottle containing 100 capsules. The bottle has a blue cap and white lettering.

    Codes: Lot# 1961645, Batch# 579391

    Quantity: 12 bottles

  • F-1133-2016 Class II

    Cranberry extract packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.

    Codes: Lot# 1961645, Batch# 579391

    Quantity: 3 bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of May 4, 2016.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.