Life sciences · Safety recall

Class II recall: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured b

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 initiated a Class II voluntary recall of Accord Healthcare levothyroxine sodium 125 mcg tablets (1000-count bottles, NDC 16729-453-17) manufactured by Intas Pharmaceuticals Limited due to subpotency. This recall affects all nationwide distribution in the United States and carries risk of therapeutic failure in patients dependent on accurate thyroid hormone replacement.

What was studied

Safety recall. Patients in the United States receiving levothyroxine sodium 125 mcg tablets from the recalled lot; those dependent on thyroid hormone replacement therapy.. United States (nationwide distribution).

Key findings

Product: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles Reason for recall: Subpotent drug distribution Recall scope: 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 should verify that patients currently taking levothyroxine sodium 125 mcg tablets from Accord Healthcare (manufactured by Intas Pharmaceuticals, NDC 16729-453-17) do not possess recalled product. Subpotent levothyroxine may result in inadequate thyroid hormone replacement, causing hypothyroid symptoms and biochemical derangement; TSH monitoring should be intensified for affected patients.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets for subpotent drug distribution; affects patients nationwide who may receive ineffective thyroid replacement therapy.

Study design

As stated by the source record.

SettingUnited States (nationwide distribution)

Reported figures

Quoted from the source exactly as published.

Product strength125 mcg (0.125 mg)

Package size1000-count bottles

NDC16729-453-17

Recall classificationClass II

Clinical bottom line

Caveats

This regulatory record does not contain clinical trial results or efficacy data.
Specific quantity of recalled units and affected lot numbers/expiration dates not stated in this enforcement report.
Mechanism or extent of subpotency (assay results, deviation from USP specification) not detailed.
Clinical outcomes in exposed patients not reported; recall scope indicates nationwide risk but individual patient impact unknown.

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

This is a regulatory enforcement action, not a clinical study.

Directness

strong

Directly addresses product quality and safety through established FDA enforcement mechanism.

Consistency

insufficient

Single recall action; consistency with other levothyroxine quality issues not discussed.

Risk of bias

insufficient

Regulatory action; bias assessment framework does not apply.

Sample adequacy

insufficient

Recall scope is nationwide distribution; specific quantity of affected units not stated.

Source abstract

FDA enforcement report D-0781-2026. 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, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17. 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