PlainRecalls
FDA Drug Moderate Class II Ongoing

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15

Reported: May 7, 2025 Initiated: April 10, 2025 #D-0397-2025

Product Description

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15

Reason for Recall

Subpotent

Details

Recalling Firm
ACCORD HEALTHCARE, INC.
Units Affected
18,984 Bottles
Distribution
Nationwide US.
Location
Raleigh, NC

Frequently Asked Questions

What product was recalled?
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15. Recalled by ACCORD HEALTHCARE, INC.. Units affected: 18,984 Bottles.
Why was this product recalled?
Subpotent
Which agency issued this recall?
This recall was issued by the FDA Drug on May 7, 2025. Severity: Moderate. Recall number: D-0397-2025.