A Class II recall has been issued for Levothyroxine Sodium Tablets USP, 150 mcg, bottle of 1000 tablets, Rx only. The recall was announced by Macleods Pharma USA, Inc., Princeton, NJ, and concerns subpotent drug product.
The tablets are manufactured by Macleods Pharmaceuticals Ltd. in Sarigam, Valsad, Gujarat, India, with NDC 33342-401-44.
The product is distributed for Macleods Pharma USA, Inc. and is categorized as a drug product.
The FDA MedWatch notice specifies subpotency as the reason for the recall, but provides no additional details on lot-specific data, distribution scope, or corrective actions beyond the classification and involved entities. Uncertainty: The recall notice does not include information on affected lot numbers, expiration dates, specific clinical implications, patient impact, or the extent of distribution.
No guidance is provided here regarding patient management, replacement product, or contact procedures for patients or providers. Clinicians and pharmacists should refer to the official FDA MedWatch notice for complete recall details and instructions.
FDA MedWatch published a clinical safety alert in Pharmacology on 01 Apr 2026.
The item focuses on LEVOTHYROXINE SODIUM: Class II recall update.
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