Life sciences · Safety recall

Class II recall: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by

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 has issued a Class II recall of levothyroxine sodium 88 mcg tablets (Accord Healthcare, NDC 16729-450-17) manufactured by Intas Pharmaceuticals for subpotent drug distribution. This is an ongoing voluntary recall affecting nationwide U.S. supply. Clinicians should be aware that affected batches may contain inadequate levothyroxine content, requiring verification of patient supply and possible therapeutic adjustment.

What was studied

Safety recall. U.S. patients prescribed levothyroxine sodium tablets, 88 mcg, with this NDC and batch exposure.. United States (nationwide distribution).

Key findings

Class II recall of levothyroxine sodium tablets, 88 mcg (0.088 mg), 1000-count bottles Reason for recall: subpotent drug distribution Nationwide distribution within the United States affected

Safety

No patient harm, adverse event reports, or clinical outcomes are reported in this record. NDC 16729-450-17; manufactured by Intas Pharmaceuticals Limited, Dehradun, India

Who this may help

Clinicians should check whether their patients are using affected levothyroxine product (NDC 16729-450-17) and consider therapeutic monitoring or product substitution. Subpotency may result in inadequate thyroid hormone replacement and loss of TSH control.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets for subpotent drug distribution affecting nationwide U.S. supply; requires immediate clinician awareness of potential product failure.

Study design

As stated by the source record.

SettingUnited States (nationwide distribution)

Reported figures

Quoted from the source exactly as published.

Drug strength88 mcg (0.088 mg)

Package size1000-count bottles

NDC16729-450-17

Recall classificationClass II

Recall statusOngoing

Clinical bottom line

Caveats

This is a regulatory record; no clinical trial data, potency assay results, or testing details are reported.
The recall reason 'subpotent' is stated but specific potency deficiency data (e.g., % of label claim) is not provided.
Affected lot numbers are not specified in this enforcement report.
No patient harm, adverse event reports, or clinical outcomes are reported in this record.

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 patient safety via regulatory action.

Consistency

insufficient

Single recall action; no comparative or historical consistency data provided.

Risk of bias

strong

Regulatory enforcement record; no bias applicable to product recall determination.

Sample adequacy

insufficient

Regulatory record does not report clinical trial or testing sample data.

Source abstract

FDA enforcement report D-0778-2026. 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, 88 mcg (0.088 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 16729-450-17. 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