The Recall Desk
HighFDA (Drugs)·D-0575-2025·Announced 2025-08-20

Levoxyl 50 microgram levothyroxine tablets recalled as a subpotent drug

Levoxyl (levothyroxine sodium tablets, USP) 50 mcg from Pfizer is being recalled because the product is subpotent. 29,004 bottles are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: a subpotent thyroid hormone tablet may under-treat the condition it is prescribed for, with no injury reported in the source.

Plain-English summary

Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottles, prescription only, distributed by Pfizer Inc. of New York and made in Austria, NDC 60793-851-01, is being recalled. The action covers 29,004 bottles.

The stated reason is a subpotent drug. The FDA classified the action as Class II.

The affected lot is 24C11, expiring 2/28/2026. Distribution was within the US.

Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Pfizer.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
Pfizer
Category
Drug — Oral tablet
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 (2)

  • Lot #: 24C11
  • Exp 2/28/2026.

UPCs (11)

  • 0360793856018
  • 0360793850016
  • 0360793852010
  • 0360793851013
  • 0360793857015
  • 0360793853017
  • 0360793854014
  • 0360793858012
  • 0360793855011
  • 0360793859019
  • 0360793860015

Distribution

Distribution scope not specified by the agency.

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