Thyroid Medication Recall 2021: Drug Called Back Over Low-Potency Risk In Hypothyroidism Treatment

Acella Pharmaceuticals has recalled for the third time a significant number of thyroid tablets because they may not be potent enough.

Acella first recalled several lots of its thyroid medication back in September 2020 because of a sub-potency issue and then again in late May 2020 because the medication was over potent, the Miami Herald noted.

In this recall, Acella has called back 35 lots of thyroid tablets that are under potent after it received 43 reports of “serious adverse events,” according to the notice posted by the Food and Drug Administration.

Patients that take thyroid tablets may have hypothyroidism, an underactive thyroid. If they take the recalled thyroid tablets that are not potent enough, they may experience signs of hypothyroidism such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland or unexplained weight gain or difficulty losing weight.

There is also a risk of early miscarriage, fetal hyperthyroidism, and impairments to fetal neural and skeletal development in newborns and pregnant women taking the drug. Those that are elderly and those with underlying cardiac disease may develop cardiac pain, palpitations, or cardiac arrhythmia.

Patients who have the affected medication in their possession should not stop taking it as the risk of discontinuing the drug without talking to a medical provider first could be greater than immediately stopping its intake, Acella said.

The medication being recalled was sold in 15, 30, 60, 90, and 120 mg doses, and according to the FDA recall notice may contain less than 90% of the labeled about of ingredient liothyronine and/or levothyroxine.

The thyroid tablets were sold in 100- and 7-count bottles. A full list of lots recalled can be viewed here. The list includes the NDC number, product description, and lot number, as well as the expiration date of the affected thyroid tablets from Acella. Images of the recalled medication can be viewed here.

The recalled medication was distributed nationwide to wholesalers, pharmacies, and healthcare offices, as well as Acella’s direct accounts.

Questions about the recall can be directed to Acella Pharmaceuticals at 1-888-424-4341, Monday through Friday from 8 a.m. to 5 p.m. ET or by email at recall@acellapharma.com.

Patients that have any problems from taking the recalled medication should contact their healthcare provider.