Food recall

Swanson Health Products, Inc recall: Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules

Swanson Health Products, Inc, of Fargo, ND, recalled Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules. The FDA's reason: “Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black...” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on September 26, 2013, and the FDA first listed it in its Enforcement Report of November 27, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed June 2, 2014

The recall

Company
Swanson Health Products, Inc (Fargo, ND)
Reason, in FDA's words
“Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359) have been found to contain White Cumin Seed (Cuminum cyminum).”
Where it was sold
US: nationwide. OUS: Australia,,Taiwan, England, Portugal, Denmark, Hong Kong, Bahrain, Thailand, Ireland, France, Poland, Macedonia, Brunei, United Arab Emirates, Israel, Japan.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66665

The product recalled

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

  • F-0220-2014 Class III

    Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6.

    Codes: 199388, 201359

    Quantity: 3689

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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 November 27, 2013.

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.