Levothyroxine Sodium tablets recalled for foreign substance contamination
Macleods Pharmaceuticals is recalling Levothyroxine Sodium 112 mcg tablets (Lot #MLF2401A, expiration 01/31/2026) distributed nationwide due to black hair found embedded in tablets.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a cosmetic defect (foreign material contamination) with no reported adverse health consequences. Class III recalls are by definition unlikely to cause adverse health consequences, warranting a score of 1.
Plain-English summary
Macleods Pharmaceuticals Ltd is recalling Levothyroxine Sodium Tablets, USP 112 mcg (0.112 mg), sold as 1000-tablet bottles, due to the presence of a foreign substance—specifically black hair—found embedded in tablets from the affected lot.
The recalled product was manufactured by Macleods Pharmaceuticals Ltd in Sarigam, Valsad, Gujarat, India, and distributed nationwide in the USA under NDC 33342-398-44. The affected lot is #MLF2401A, with expiration date 01/31/2026. Approximately 1,344 bottles of the 1000-count size are involved.
Patients taking this medication should verify their bottle's lot number against the recall information. If you have tablets from Lot #MLF2401A, contact your pharmacist or healthcare provider for guidance on obtaining unaffected replacement medication. Do not use tablets from the affected lot.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Macleods Pharmaceuticals Ltd
- Category
- Drug — Prescription Tablets
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.
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