RecallRadar

FDA Drug recall D-0395-2025

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Ma…

On 2025-05-07 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Ma… by Accord Healthcare, citing subpotent.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0395-2025
ClassificationClass II
Statusongoing
Initiated2025-04-10
Published2025-05-07
Last updated2026-09-13 11:52 UTC
CompanyAccord Healthcare
DistributionUS

Product

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.

Reason

Subpotent

Identifiers

ndc16729-458-15
ndc16729-458-17
ndc16729-447-15
ndc16729-447-17
ndc16729-448-15
ndc16729-448-17
ndc16729-449-15
ndc16729-449-17
ndc16729-451-15
ndc16729-451-17
ndc16729-450-15
ndc16729-450-17
ndc16729-452-15
ndc16729-452-17
ndc16729-453-15
ndc16729-453-17
ndc16729-454-15
ndc16729-454-17
ndc16729-455-15
ndc16729-455-17
ndc16729-456-15
ndc16729-456-17
ndc16729-457-15
ndc16729-457-17
code_infoLot # D2400547, Exp Date: 02/2026

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0395-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.