The Recall Desk
CriticalFDA (Drugs)·D-1298-2020·Announced 2020-06-10

Acella Recalls Superpotent NP Thyroid 15 Tablets Nationwide

Acella Pharmaceuticals is voluntarily recalling 112,140 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers distribution across the US and Puerto Rico.

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 FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).

Plain-English summary

Acella Pharmaceuticals, LLC is voluntarily recalling 112,140 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) tablets. The product is a prescription-only thyroid medication manufactured in Alpharetta, Georgia, and distributed nationwide in the United States and Puerto Rico.

The recall was initiated because the drug is classified as superpotent. A superpotent drug is one where a small deviation in the amount of active ingredient can result in a significant change in the drug's effect, potentially leading to serious adverse health consequences. The FDA has classified this recall as Class I, which is the most serious classification.

Patients who have been prescribed NP Thyroid 15 should contact their healthcare provider for guidance on alternative treatment options. The recall was initiated on May 22, 2020, and was terminated on January 19, 2022. Specific lot numbers and expiration dates are listed in the official recall documentation.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Thyroid Medication
Hazard
Affected units
112,140

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 (7)

  • Lots: M329H18-1
  • Exp. JUL-2020
  • M329J18-1
  • M329J18-2
  • M329J18-3 Exp. AUG-2020
  • M329M18-2 Exp. NOV-2020
  • M329A19-1 Exp. DEC-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 →

Related recalls

Same brand · NP THYROID 15

Same manufacturer · Acella Pharmaceuticals, LLC

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Same hazard · superpotent drug

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