Thyroid Drugs Recalled, Pose Risk to Newborns, Pregnant Women and Elderly

Thyroid drugs have been recalled after the manufacturer found they posed a risk to newborn infants, pregnant women and the elderly.

According to the Food and Drug Administration (FDA), Acella Pharmaceuticals, LLC, the manufacturer of NP Thyroid 15mg and 120mg tablets, has voluntarily requested the return of the drug due to sub potency of levothyroxnie. In some tests of the tablets, the company found that the levels were 87 percent lower than labelled.

In its announcement made on September 17, 2020, Acella Pharmaceuticals says that patients taking these drugs are being treated for hypothyroidism—an underactive thyroid. However, those who take the subpotent NP Thyroid could experience symptoms of this condition, which could lead to serious injury in newborn infants or pregnant women with hypothyroidism.

According to the recall, symptoms could include:

  • Fatigue.
  • Increased sensitivity to cold.
  • Constipation.
  • Dry skin.
  • Puffy face.
  • Hair loss.
  • Slow heart rate.
  • Depression.
  • Swelling of the thyroid gland.
  • Unexplained weight gain or difficulty losing weight.

"There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development," says the Acella announcement. "In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia."

To date, Acella has confirmed it has received four reports of adverse events for the following lot numbers, possibly related to this recall. The products subject to recall are packed in 100-count bottles.

ProductNDCLot #Exp. Date
NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg)42192-327-01M327E19-1October 2020
NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg)42192-328-01M328F19-3November 2020

According to the company announcement on the FDA website, these lots were "distributed nationwide in the USA to Acella's direct accounts." These include wholesalers, pharmacies, and healthcare offices. People using the tablets might also be able to determine that their product is not impacted by the recall if the "use by," "discard after," or "expiration date" on their prescription bottle is on or after December 2020, says the announcement.

Acella Pharma Tablets
Acella Pharma Tablets
NP Thyroid 15mg and 120mg is being recalled by Acella Pharmaceuticals LLC

"Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products," the company says in its recall announcement. "Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription."

Questions regarding the recall should be directed to Acella Pharmaceuticals via email——or by phone at 1-888-280-2044. Lines are open Monday through Friday from 8:00 a.m. to 5:00 p.m. ET.

For those experiencing any problems that could be related to taking this drug, they are advised by Acella to contact their physician or healthcare provider. FDA says that adverse reactions or quality problems experienced with the use of this product can be reported to the MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or
  • Fax: Submit to 1-800-FDA-0178
Acella Pharmaceuticals LLC Recall Labels
Acella Pharmaceuticals LLC Recall Labels
Labels of the recalled NP Thyroid tablets.