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Drug FDA Class II Ongoing Sub/super-potent

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17

ACCORD HEALTHCARE, INC. Published May 7, 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

Affected products (1)

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17

LEVOTHYROXINE SODIUM · 4,888 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: D2300323
Code info: Lot # D2300323, Exp Date: 01/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 10, 2025
  2. Published
    May 7, 2025
Recall number
D-0394-2025
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.