The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1299-2020·Announced 2020-06-10

Acella Recalls NP Thyroid 15 Tablets Due to Superpotent Drug Risk

Acella Pharmaceuticals is voluntarily recalling 29,304 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers products distributed nationwide in the US and Puerto Rico.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.

Plain-English summary

Acella Pharmaceuticals, LLC has voluntarily initiated a recall of 29,304 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) tablets. The recall was initiated because the product is classified as a superpotent drug, which presents a significant risk of serious adverse health consequences or death if used incorrectly or in excess.

The affected product is NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, which are prescription-only. The specific lots involved are M330J18-2A and M330J18-3, both with an expiration date of August 2020. The product was distributed nationwide in the United States and Puerto Rico.

Consumers and healthcare providers should stop using the affected product immediately. Patients should consult their healthcare provider for alternative treatment options. The recall was initiated by the firm and was later terminated by the FDA.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Thyroid Hormone
Hazard
Affected units
29,304

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 (2)

  • Lots: M330J18-2A
  • M330J18-3 Exp. AUG-2020

UPCs (4)

  • 0342192329102
  • 0342192330108
  • 0342192327016
  • 0342192328013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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