← FDA ENFORCEMENT
D-0006-2026Class II

ACCORD HEALTHCARE, INC.

Recalling firm
ACCORD HEALTHCARE, INC.
Product type
Drug
Status
Ongoing
Report date
2025-10-15
Distribution
Nationwide in the US
Firm state
NC
Product quantity
54,432 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Product description

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.

Code / lot info

Lot # D2300045, Exp 12/31/2025.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.