Life sciences · Safety recall

Class II recall: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Man

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 137 mcg tablets (two package sizes) manufactured by Intas Pharmaceuticals Limited and distributed by Accord Healthcare, Inc., due to subpotent drug distribution nationwide in the United States. This is an ongoing voluntary recall initiated by the firm; the specific clinical consequences, number of affected units, or clinical test results documenting the potency deficiency are not reported in this enforcement document.

What was studied

Safety recall. Patients taking levothyroxine sodium 137 mcg tablets distributed nationwide in the United States from affected batches.. Manufactured in Dehradun, India; distributed nationwide within the United States.

Key findings

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg) recalled in two package configurations: 90-count bottles (NDC 16729-454-15) and 1000-count bottles (NDC 16729-454-17) Reason for recall: Subpotent Drug Distribution Recall is ongoing and nationwide within the United States

Safety

No clinical trial data, adverse event counts, or patient outcomes are provided in this regulatory record.

Who this may help

Clinicians and patients should be aware that affected levothyroxine tablets may contain subpotent drug, potentially leading to inadequate thyroid hormone replacement. Patients on affected lots should be notified to obtain replacement product and may require thyroid function testing to assess adequacy of current therapy.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets for subpotent drug distribution; a safety action requiring immediate attention but not a clinical trial.

Study design

As stated by the source record.

SettingManufactured in Dehradun, India; distributed nationwide within the United States

Reported figures

Quoted from the source exactly as published.

Product strength137 mcg (0.137 mg)

Recall classificationClass II

Recall initiationVoluntary: Firm initiated

Geographic scopeNationwide within the United States

Clinical bottom line

Caveats

The enforcement document does not report the potency range found, number of affected units, lot numbers, or distribution dates.
No clinical trial data, adverse event counts, or patient outcomes are provided in this regulatory record.
The specific mechanism of subpotency (manufacturing defect, degradation, stability issue) is not described.
No information on recall effectiveness or completion status is included in this notice.

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

insufficient

Recall addresses product quality; clinical outcomes not reported.

Consistency

insufficient

Single enforcement action; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory enforcement record.

Sample adequacy

insufficient

Not applicable to regulatory enforcement record.

Source abstract

FDA enforcement report D-0782-2026. 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, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), 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