Macleods levothyroxine 150 microgram tablets recalled as a subpotent drug
Macleods Pharma USA is recalling one lot of Levothyroxine Sodium Tablets USP 150 mcg because the product is subpotent.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a subpotent thyroid hormone tablet delivers less than the labelled dose, and no injuries are stated in the source.
Plain-English summary
Macleods Pharma USA, Inc is recalling Levothyroxine Sodium Tablets USP 150 mcg, in 1,000-tablet bottles, prescription only, made in Sarigam, Gujarat, India, NDC 33342-401-44. About 1,315 bottles were distributed nationwide. The FDA has classified this recall as Class II, and the firm initiated it voluntarily.
The recall was initiated because the product is a subpotent drug.
Affected product is lot 16240062A with an expiry date of 3/2026.
Patients and pharmacies can identify affected product by the NDC and lot number above, and may contact Macleods Pharma USA, Inc for further information.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- MACLEODS PHARMA USA, INC
- Category
- Drug — Prescription tablet
- Affected units
- 1,315
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 16240062A
- exp date 3/2026
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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