D-0006-2026 Class II Ongoing
FDA drug recall D-0006-2026 was initiated by ACCORD HEALTHCARE, INC. on September 16, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 54,432 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2025
- Initiation Date
- September 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,432 bottles
Product Description
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.
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 Pattern
Nationwide in the US
Code Information
Lot # D2300045, Exp 12/31/2025.