The Recall Desk
ModerateFDA (Drugs)·D-0470-2025·Announced 2025-06-18

Levothyroxine Sodium Tablets Recalled for Foreign Substance Contamination

Macleods Pharmaceuticals is recalling Levothyroxine Sodium Tablets (112 mcg, Lot #MLF2401A) due to a black hair found embedded in tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recalls with low-risk contamination (foreign substance without reported illness) and no evidence of harm are classified as Moderate per the rubric criterion 'low-risk contamination, voluntary precautionary recalls.'

Plain-English summary

Macleods Pharmaceuticals Ltd is recalling Levothyroxine Sodium Tablets, USP 112 mcg (Lot #MLF2401A, Expiration 01/31/2026), distributed nationwide in the USA. The product is available in 1,344 bottles of 1,000 tablets each. The medication is manufactured in India by Macleods Pharmaceuticals Ltd for Macleods Pharma USA, Inc. (Princeton, NJ).

The recall was issued due to the presence of a black hair embedded in tablets.

Consumers who have this medication with the affected lot number should contact their pharmacist or healthcare provider regarding this recall. Patients should not use the affected lot and should obtain replacement medication from their pharmacy.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Macleods Pharmaceuticals Ltd
Category
Drug
Hazard
  • foreign-object
  • contamination

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 #: MLF2401A
  • Exp 01/31/2026

UPCs (13)

  • 0333342393104
  • 0333342397102
  • 0333342404107
  • 0333342393111
  • 0333342400109
  • 0333342403100
  • 0333342393449
  • 0333342394101
  • 0333342402103
  • 0333342396105
  • 0333342395108
  • 0333342398109
  • 0333342399106

Distribution

Distributed nationwide across the United States.