Macleods Pharma USA, Inc. recalls 1,315 bottles of Levothyroxine Sodium Tablets USP 150 mcg distributed nationwide. The drug is subpotent, which may not provide the full therapeutic dose. Stop using and contact your healthcare provider or Macleods Pharma USA, Inc. for guidance.
Subpotent Drug
Consumers and healthcare providers should stop using this product immediately. Contact MACLEODS PHARMA USA, INC or your healthcare provider for guidance. Notification method: Letter
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Levothyroxine Sodium Tablets USP 150 mcg, 1000-tablet bottle. Rx Only. NDC 33342-401-44. Manufactured for Macleods Pharma USA, Inc., Princeton, NJ. Manufactured by Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Gujarat, India. Lot 16240062A. Exp 3/2026. Quantity: 1315 bottles. Distributed nationwide.
The product is subpotent, meaning it may deliver less than the labeled dose. Inadequate thyroid hormone replacement can lead to under-treatment of hypothyroidism.
No injuries or incidents have been reported.
1. Stop using the product. 2. Check the bottle for Lot 16240062A and Exp 3/2026. 3. Contact Macleods Pharma USA, Inc. or your healthcare provider for guidance. 4. Do not dispose of the product until advised. 5. If you experience symptoms of hypothyroidism, contact your clinician promptly.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0403-2026. For guidance, contact Macleods Pharma USA, Inc. directly or your healthcare provider.
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