Accord Healthcare recalls levothyroxine sodium tablets 88 mcg over weaker-than-labeled strength
During long term stability testing of the 88 mcg tablets, the amount of active ingredient was found to be below the approved range, so the tablets are subpotent.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.
- Hazard
- Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
- Units
- 54,432 bottles
- Where sold
- Nationwide in the US
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 6, 2025
- Recall started
- September 16, 2025
- FDA enforcement report
- October 15, 2025
- Identifiers
- Codes: Lot # D2300045, Exp 12/31/2025.
- FDA recall number: D-0006-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the US
- Quantity
- 54,432 bottles
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