Life sciences · Safety recall

Class II recall: Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), 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 has initiated a Class II voluntary recall of levothyroxine sodium 175 mcg tablets manufactured by Intas Pharmaceuticals Limited for Accord Healthcare, Inc., due to subpotency (below-label potency) in distributed batches. This recall affects two package sizes (90-count and 1000-count bottles) distributed nationwide and requires healthcare providers and patients to verify product batch numbers and consider therapeutic adequacy in patients taking affected lots.

What was studied

Safety recall. Patients prescribed levothyroxine sodium 175 mcg tablets and distributors in the United States receiving the affected batches. United States (nationwide).

Key findings

Class II recall initiated for levothyroxine sodium tablets 175 mcg due to subpotent drug distribution Two affected package sizes: 90-count bottles (NDC 16729-456-15) and 1000-count bottles (NDC 16729-456-17) Recall status: Ongoing, voluntarily initiated by Accord Healthcare, Inc.

Safety

No clinical trial data, safety reports, or patient harm data are included in this regulatory notice Distribution scope is nationwide but specific healthcare facilities or pharmacies are not identified in this summary

Who this may help

Clinicians should verify whether patients taking levothyroxine 175 mcg from the specified NDC numbers are receiving subpotent product, assess for inadequate thyroid hormone replacement (elevated TSH, persistent hypothyroid symptoms), and consider switching affected patients to alternative batches or manufacturers. Subpotency may result in treatment failure and symptom recurrence.

Plain-language summary

FDA Class II recall of levothyroxine sodium tablets due to subpotency, affecting drug distribution nationwide and requiring clinical awareness of affected batches.

Study design

As stated by the source record.

SettingUnited States (nationwide)

Reported figures

Quoted from the source exactly as published.

Drug strength175 mcg (0.175 mg)

NDC – 90-count bottles16729-456-15

NDC – 1000-count bottles16729-456-17

Recall classificationClass II

Recall statusOngoing

Clinical bottom line

Caveats

Recall record does not specify which lot numbers or date ranges are affected; clinicians must consult FDA enforcement details for complete batch information
No quantitative data on degree of subpotency (e.g., % below label claim) is provided in this record
No clinical trial data, safety reports, or patient harm data are included in this regulatory notice
Distribution scope is nationwide but specific healthcare facilities or pharmacies are not identified in this summary

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; no clinical study design

Directness

strong

Direct regulatory action identifying affected product batches and NDC numbers

Consistency

insufficient

Single regulatory action; no comparative or replicated data reported

Risk of bias

insufficient

Regulatory record; bias assessment not applicable to enforcement action

Sample adequacy

insufficient

Regulatory action affecting nationwide distribution; no sample size metric

Source abstract

FDA enforcement report D-0784-2026. 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, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), 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