Thyroid Medication Recalled for Being Too Weak

Acella Pharmaceuticals, LLC is recalling some of its NP Thyroid® tablets because they are not strong enough to work properly, according to an announcement published by the Food and Drug Administration (FDA) Thursday. Patients with underactive thyroids, technically known as hypothyroidism, who take weaker medicine may experience symptoms of the condition. These include fatigue, dry skin, low heart rate, depression and unexpected weight loss or gain.

“To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall,” the company said.

The recall marks the second time this month that a thyroid drug was pulled for being too weak, or subpotent, the Miami Herald pointed out. RLC Labs, Inc. recalled nearly 500 lots of Nature-Throid® and WP Thyroid® for the same reason Sept. 3. Weeks before that, several lots of thyroid medication were recalled for being too strong, SlashGear reported.

The most recent recall concerns one lot of Acella’s 15-mg NP Thyroid® and one lot of its 120-mg NP Thyroid®. The recall comes because testing revealed the lots to be subpotent. They may contain as little as 87 percent of the amount of levothyroxine, or T4, indicated on the label.

“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 said in the 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.”

Pregnant or elderly patients with hypothyroidism face additional risks if they take subpotent medication. For pregnant people, the weakened drug could cause early miscarriage or damage to the fetus such as impairment of skeletal or brain development or the onset of fetal hyperthyroidism. In elderly patients or patients with preexisting heart conditions, taking the weakened drugs could lead to palpitations, heart pain or cardiac arrhythmia.

The recalled products were packed in 100-count bottles and had expiration dates of Oct. and Nov. 2020. Their lot numbers were M327E19-1 and M328F19-3.

“[C]onsumers may 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,” the recall notice said.

If patients experience any harmful side effects from taking the medication, they should contact their healthcare providers. They can also report the adverse reaction to the FDA’s MedWatch Adverse Event Reporting program here.

Anyone with questions about the recall can contact Acella Pharmaceuticals at recall@acellapharma.com or 1-888-280-2044.