Sundial Herbal Products Recalled as ‘Unapproved Drugs’

Sundial Herbal Products

If you regularly purchase herbs and supplements as part of your healthcare regimen, take note of this massive recall!

Sundial Herbal Products is recalling all of their products with a manufacture date of 2014 or later.  The recall follows the U.S. Food and Drug Administration (FDA) deeming them “unapproved drugs.” The FDA and Sundial are requesting immediate removal and return of all products.  Read on to learn more about the recall and what you should do if you take Sundial Herbal Products on a regular basis.

Sundial Herbal Products Recall

According to the FDA Company Announcement, Sundial Herbal Products labels contain language that states or claims that the products can “diagnose, cure, mitigate, treat or prevent disease.” The FDA says that these claims are misleading and the products are misbranded.  The FDA says,

“The recalled drug products are misbranded and deemed unapproved drugs based on labeling claims which could result in a delay of appropriate treatment by a healthcare provider.”

Because the Sundial products are unapproved, the safety and efficacy of the products cannot be established.  Additionally, the FDA says that the agency cannot identify or assess possible risks to patients who use the products.

What Products are Subject to Recall?

Consumers who regularly purchase Sundial products may find that their favorite herb or blend is subject to this recall.  All of the products subject to this recall will include the Sundial label.  The product packages include brown glass bottles, boxes, paper bags and Ziploc bags.  Some of the most popular products subject to the recall include:

  • Diabetics
  • Flax Seed Oil
  • Mitmitta (Cayenne pepper)
  • Asthma
  • Blood pressure
  • Heart
  • Flu-Allergies/HayFever
  • Arthritis
  • Hemp Seed Oil
  • Blue Vervain

For a full list of the products subject to recall, visit the FDA Company Announcement.  The products were available at the Sundial website, through other websites and at a storefront location in Bronx, New York.

What to Do if You Take a Recalled Product

If you regularly take a product made by Sundial, the FDA advises that you stop immediately.  If you have any health problems related to taking Sundial products, contact your healthcare provider.  Provide details about what you are taking and your symptoms.  Also, mention that your product is subject to a recall.

The FDA reports no illnesses at this time.  However, they are asking consumers to report any adverse events related to Sundial Herbal Products using the MedWatch Adverse Event Reporting program.  You can file a report with MedWatch online, by mail or by fax.

For retailers, the FDA says you can contact Sundial Herbal Products to arrange for a return.  The manufacturer will dispose of or destroy products returned.  Consumers or retailers with questions about the recall can call Sundial at (718) 798-3962.

Have Questions?

As always, if you have questions or concerns about a product recall and your legal rights, you can contact Drug and Device Watch. For a free legal consultation, call 1-888-458-6825.