Life sciences · Safety recall

Class II recall: Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only,

U.S. Food and Drug Administration · September 2, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA issued a Class II recall of levothyroxine sodium 100 mcg tablets (NDC 16729-451-15 and NDC 16729-451-17) manufactured by Intas Pharmaceuticals Limited for subpotency. This is an ongoing voluntary recall initiated by Accord Healthcare affecting nationwide distribution.

What was studied

Safety recall. Patients nationwide in the United States using levothyroxine sodium tablets from affected lots.. United States (nationwide distribution).

Key findings

Levothyroxine sodium 100 mcg tablets found to be subpotent Two package sizes affected: 90-count and 1000-count bottles Distributed nationwide within the United States

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Clinicians and patients should verify whether their levothyroxine supply is from affected lot numbers. Subpotent thyroid replacement may result in inadequate hypothyroidism treatment and thyroid stimulating hormone elevation; affected patients should contact their pharmacy or prescriber for alternative supply.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets for subpotency; affects patients nationwide and requires immediate awareness of affected lot numbers.

Study design

As stated by the source record.

SettingUnited States (nationwide distribution)

Reported figures

Quoted from the source exactly as published.

Dose100 mcg (0.1 mg)

NDC (90-count)16729-451-15

NDC (1000-count)16729-451-17

Recall classificationClass II

Recall statusOngoing

Clinical bottom line

Caveats

This record does not contain clinical trial results or efficacy data.
Specific lot numbers affected are not provided in this enforcement report.
Quantity of affected product distributed is not quantified.
The mechanism or extent of subpotency is not detailed.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory enforcement action, not a clinical study.

Directness

strong

Directly addresses product quality and patient safety issue.

Consistency

insufficient

Single recall action; no comparative or replication data provided.

Risk of bias

insufficient

Not applicable to regulatory enforcement record.

Sample adequacy

insufficient

Nationwide distribution scope noted; specific quantity not quantified.

Source abstract

FDA enforcement report D-0779-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: ACCORD HEALTHCARE, INC.. Initiated as: Voluntary: Firm initiated. Product: Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Reason for recall: Subpotent Drug Distribution: Nationwide within the United States

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Accord Healthcare