Life sciences · Safety recall

Class II recall: Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, M

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 voluntary recall of levothyroxine sodium 200 mcg tablets manufactured by Intas Pharmaceuticals Limited and distributed by Accord Healthcare, Inc., due to subpotency affecting the drug's therapeutic efficacy. The recall is ongoing and applies to all affected product lots distributed nationwide in the United States.

What was studied

Safety recall. Patients receiving levothyroxine sodium 200 mcg tablets distributed nationwide in the United States. United States (nationwide).

Key findings

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg) found to be subpotent Two package sizes recalled: 90-count bottles (NDC 16729-457-15) and 1000-count bottles (NDC 16729-457-17) Nationwide distribution within the United States affected

Safety

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

Who this may help

Clinicians should be aware that patients may have received subpotent levothyroxine sodium tablets, potentially resulting in inadequate thyroid hormone replacement. Patients on affected lots should be identified and provided alternative product to prevent clinical deterioration.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets for subpotency; affects product safety and efficacy in patients nationwide.

Study design

As stated by the source record.

SettingUnited States (nationwide)

Reported figures

Quoted from the source exactly as published.

Product strength200 mcg (0.2 mg)

Recall classificationClass II

Recall statusOngoing

Clinical bottom line

Caveats

No clinical trial data or efficacy comparisons provided in this regulatory record
Specific potency levels or testing results not reported
Lot numbers and specific distribution dates not detailed in this summary
Impact on patient outcomes not quantified

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 impact.

Consistency

insufficient

Single regulatory action; consistency with other recalls not reported.

Risk of bias

insufficient

Not applicable to regulatory enforcement records.

Sample adequacy

insufficient

No clinical trial data; nationwide distribution scope noted.

Source abstract

FDA enforcement report D-0785-2026. 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, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), 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