Drug & medication recalls Moderate risk

ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I…

Recall date
June 20, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0521-2025
FDA classification
Class II
Brand / firm
ACCORD HEALTHCARE, INC.
Sold / distributed
Nationwide in the USA

Why it was recalled

Subpotent Drug: Assay below the approved specification

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17

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