Brigette Honaker  |  September 22, 2020

Category: Legal News

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A doctor performs a thyroid ultrasound on a female patient - thyroid medication

The FDA recently announced the recall of two lots of NP Thyroid medication due to concerns that the products can lead to serious hypothyroidism issues.

The agency says these issues stem from the fact that the affected lots have been found to have as low as 87% of the labeled active ingredient amount. NP Thyroid’s manufacturer has voluntarily recalled these products and will reportedly continue to test current lots of the drug for any additional issues.

NP Thyroid Medication: Overview

NP Thyroid is manufactured by Acella Pharmaceuticals as a treatment of hypothyroidism. Patients with this condition have a thyroid that can’t make enough thyroid hormone. This can lead to serious issues as the body struggles to function without an essential hormone.

Symptoms of hypothyroidism can vary, but may include feeling cold, dry skin, forgetfulness, depression, constipation and more. Patients may take NP thyroid in an attempt to curb these and other symptoms.

Unfortunately, two lots of NP Thyroid were recently recalled after it was discovered that the drugs failed to effectively treat hypothyroidism due to substandard amounts of the active ingredient.

Thyroid Medication Recall

The U.S. Food and Drug Administration (FDA) announced the NP Thyroid medication recall Sept. 17, the same day that Acella voluntarily recalled the products.

According to the FDA, the recalled lots of NP Thyroid medication do not have enough of the active ingredient levothyroxine (T4).

Because the levels of this drug may be as low as 87% of the labeled amount, patients are reportedly experiencing signs of hypothyroidism.

The FDA notes this can include a wide range of issues such as cold sensitivity, constipation, dry skin, a swollen or puffy face, hair loss, depression, slow heart rate, swelling of the thyroid, or unexplained weight gain.

Newborn infants and pregnant woman are reportedly at an increased risk for hypothyroidism and its consequences. The FDA warns that hypothyroidism could lead to early miscarriage, fetal hyperthyroidism and fetal impairments in neural and skeletal development.

A glowing blue graphic of a male body with the thyroid highlighted in red - thyroid medication

Older people are reportedly also at risk for hypothyroidism complications if they suffer from cardiac disease. Hypothyroidism in these patients can reportedly lead to cardiac pain, heart palpitations or cardiac arrhythmia.

Acella has reportedly received four reports of adverse events related to the affected lots.

One lot of the 15 mg dosage and one lot of the 120 mg dosage are affected by the recall. Patients and pharmacists can identify the drugs based on the following information:

  • NP Thyroid® 15 mg Thyroid Tablets
    • NDC: 42192-327-01
    • Lot #: M327E19-1
    • Expiration Date: October 2020
  • NP Thyroid® 120 mg Thyroid Tablets
    • NDC: 42192-328-01
    • Lot #: M328F19-3
    • Expiration Date: November 2020

According to the FDA, Acella is notifying wholesalers about the issue via email and phone calls. In addition, the company will reportedly continue to test lots of non-expired NP Thyroid medication to make sure no other lots are affected by the issue.

“I am very disappointed that any product we make is less than perfect,” Acella CEO Harold Deas Jr. wrote in a product update. “Missing the mark by even a few percentage points is not acceptable to me. That is why we are continuing to retest every lot of NP Thyroid that is still on the market and within its expiration date.”

“That’s our commitment to quality at Acella. Our patients will come first in all that we do.”

This Acella thyroid medication is not the first of its kind nor is it the only recall to be announced recently, according to the Miami Herald.

Earlier this month, RLC Labs Inc. voluntarily recalled all lots of their Nature-Thyroid and WP Thyroid medications due to concerns of subpotency.

As in the Acella NP Thyroid medication recall, this recall was motivated by concerns that the products could lead to dangerous hypothyroidism in patients. However, unlike Acella, RLC Labs had not received any reports of adverse events.

The FDA encourages patients taking a recalled thyroid medication to discuss the issue with their doctor before discontinuing their medication. The agency stresses the importance of finding a replacement treatment before stopping any medication.

If you or a loved one has experienced adverse symptoms in connection with recalled thyroid medication, the FDA encourages you to seek help from a medical professional.

Then you can report the issue to the FDA’s MedWatch Adverse Event Reporting system.

This database helps the FDA keep track of adverse events associated with medications and medical devices — helping the agency know when to recall or warn about a product.

Have you taken thyroid medication that has now been recalled? Share your experiences in the comment section below.

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108 thoughts onThyroid Medications Recalled Across US After Reports of Problems

  1. Edna Rice says:

    I received a letter telling me the medication was recalled. I experienced a stroke and my TSH over 54. My thyroid went into a whirlwind. My TSH is over 10 currently. Still having a terrible time getting myself regulated.

  2. Katerina says:

    I was affected by this recall and thought I was losing my mind. Dealt with very severe depression. No one should have to experience this!

  3. Marilyn hawkins says:

    Taking level thyroxine, and having all the symptoms that are talked about on the profile

  4. Judy A Morrow says:

    I have been taking levothyroxine for years I have the same symptoms as everyone else please add me to your list.

  5. Judy A Morrow says:

    I have been taking levothyroxine for years I have the same symptoms as everyone else please add me to your list. can’t lose weight sensitive to cold fatigue nausea and tremors in both hands. also dry skin loss of sleep.

  6. Penny Fox says:

    Please add me I take Levothyroxine

  7. Patricia Mccurdy says:

    I felt as though i was in a very deep depression, no energy, very sore joints,weight gain, heart palpitations, body temperature hot then cold. And no warning from company or CVS. I actually thought i was dying

  8. Trenna Barnes says:

    I have been taking np thyroid pills for a year now and have experienced hair loss, weight gain,fatigue, extreme cold, sleeplessness, pain in my joints,and various other things.

  9. legend Tinawin says:

    what brand and med did they change you to, now that you are feeling better?

  10. Patricia Whitaker says:

    I WAS ON ARMOUR FOR OVER 8 LONG MONTHS TELLING MY DR. I FELT AS IF I WAS A CHEMO PT. NEVER HAD CANCER BUT FELT LIKE IT EVERYDAY . THE FATIGUE-MEMORY LOSS – HAIR LOSS – IRRITABILITY – INSOMNIA – EXTREME ANXIETY W 6 WEEK LAB NUMBERS OF 16 ONE MONTH WHEN 2 IS NORMAL AND DR. THINKING I WASN’T TAKING MY MEDICATION RIGHT IT WAS A HORRIBLE ROLLERCOASTER FOR A YEAR.. SOMEONE SHOULD BE LIABLE NO ONE SHOULD FEEL THE WAY I DID OR ANY OTHERS LISTED ABOVE.. I.AM ON NAME BRAND SYNTHROID NOW AND JUST NOW GETTING BACK TO MYSELF W LIMITATIONS STILL.. HORRIBLE.. SHOULDN’T HAPPEN .. CLASS ACTION SUIT NEEDS FILED..ASAP FOR EVERY EFFECTED PATIENT.. STAT..

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