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Drug FDA Class II Ongoing Sub/super-potent

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.

ACCORD HEALTHCARE, INC. Published Oct 15, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact ACCORD HEALTHCARE, INC. or your place of purchase with questions, and see the source record below for full details.
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.

Hazards

Subpotency · primary

Affected products (1)

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.

LEVOTHYROXINE SODIUM · 54,432 bottles

NDC: 16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453, 16729-454, 16729-455, 16729-456, 16729-457, 16729-458-15, 16729-458-17, 16729-447-15, 16729-447-17, 16729-448-15, 16729-448-17, 16729-449-15, 16729-449-17, 16729-451-15, 16729-451-17, 16729-450-15, 16729-450-17, 16729-452-15, 16729-452-17, 16729-453-15, 16729-453-17, 16729-454-15, 16729-454-17, 16729-455-15, 16729-455-17, 16729-456-15, 16729-456-17, 16729-457-15, 16729-457-17
Lot codes: D2300045
Code info: Lot # D2300045, Exp 12/31/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 16, 2025
  2. Published
    Oct 15, 2025
Recall number
D-0006-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.