The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0396-2021·Announced 2021-06-02

Acella Recalls Subpotent NP Thyroid 15 Prescription Tablets

Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because they contain less active ingredient than labeled. The recall covers specific lots distributed nationwide.

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 corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Acella Pharmaceuticals, LLC has voluntarily recalled specific lots of NP Thyroid 15 (levothyroxine, liothyronine) thyroid tablets. The recall was initiated because the affected tablets are subpotent, meaning they contain less of the active drug ingredients than stated on the label.

The recall includes 100-count bottles (NDC 42192-329-01) and 7-count bottles (NDC 42192-329-07) of the 1/2 grain (30 mg) strength. The affected lots are M329D20-1, M329D20-2, and M329D20-3, all with an expiration date of 03/31/2022. A total of 113,019 bottles of the 100-count size and 44,900 bottles of the 7-count size are involved.

These prescription-only medications were distributed nationwide within the United States, including Puerto Rico. The FDA has classified this recall as Class I, which is the most serious classification, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death. Patients should contact their healthcare provider for guidance on managing their thyroid condition during this recall.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Prescription Medication
Hazard

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 (4)

  • Lots: a) M329D20-1
  • M329D20-2
  • M329D20-3 Exp. 03/31/2022
  • b) M329D20-2 Exp. 03/31/2022

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 5 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 5 products in this recall →

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