The Recall Desk
CriticalFDA (Drugs)·D-0035-2021·Announced 2020-10-28

Acella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine

Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because FDA analysis found the levothyroxine content was less than the labeled claim.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Acella Pharmaceuticals, LLC is recalling 19,296 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) Thyroid Tablets, USP 1/4 grain (15 mg). The affected product is identified by Lot # M327E19-1 with an expiration date of 10/2020. The product was distributed nationwide within the United States.

The recall was initiated because FDA analysis determined that the products were subpotent, meaning they contained less levothyroxine (T4) than stated on the label. This discrepancy means patients may not receive the intended therapeutic dose of the medication.

Consumers who have this specific lot of NP Thyroid 15 should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Affected units
19,296

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: M327E19-1 Exp. 10/2020

UPCs (4)

  • 0342192329102
  • 0342192330108
  • 0342192327016
  • 0342192328013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Acella Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · NP THYROID 15