RecallDepth
Class II Ongoing

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

Company
Accord Healthcare, Inc.
Recall Initiated
September 16, 2025
Posted
October 15, 2025
Recall Number
D-0006-2026
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
54,432 bottles
Firm Location
Raleigh, NC, United States

Reason for Recall

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Distribution

Nationwide in the US

Lot / Code Info

Lot # D2300045, Exp 12/31/2025.

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