PlainRecalls
FDA Drug Moderate Class II Ongoing

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 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 16729-455-17

Reported: July 23, 2025 Initiated: June 20, 2025 #D-0523-2025

Product Description

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 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 16729-455-17

Reason for Recall

Subpotent Drug: Assay below the approved specification

Details

Recalling Firm
ACCORD HEALTHCARE, INC.
Units Affected
4,921 bottles
Distribution
Nationwide in the USA
Location
Raleigh, NC

Frequently Asked Questions

What product was recalled?
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 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 16729-455-17. Recalled by ACCORD HEALTHCARE, INC.. Units affected: 4,921 bottles.
Why was this product recalled?
Subpotent Drug: Assay below the approved specification
Which agency issued this recall?
This recall was issued by the FDA Drug on July 23, 2025. Severity: Moderate. Recall number: D-0523-2025.