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.
This recall is currently active, issued October 15, 2025. It was issued by Accord Healthcare, Inc..
- 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
- Official Source
- View on FDA website ↗
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.
More recalls by Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for:...
Jul 23, 2025 · Class II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord...
May 7, 2025 · Class II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for:...
Dec 11, 2024 · Class II
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