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Drug FDA Class II Ongoing Sub/super-potent

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17

ACCORD HEALTHCARE, INC. Published Dec 11, 2024

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 drug

Hazards

Subpotency · primary

Affected products (1)

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17

LEVOTHYROXINE SODIUM

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
Code info: Lot #: D2300191, Exp 12/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 8, 2024
  2. Published
    Dec 11, 2024
Recall number
D-0076-2025
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.