Agency classClass IIOur severity:High FDA (Drugs)·D-0780-2026·Announced 2026-09-02

Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets

Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 112 mcg tablets because they are subpotent. The recall covers nationwide distribution.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a subpotent drug, which poses a risk of therapeutic failure for a chronic condition, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles. The recall is initiated because the product is subpotent, meaning it may not contain the full labeled amount of the active ingredient. The affected product is manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide within the United States.

The recall affects specific lots with expiration date 10/31/2026. The lot numbers are D2402443, D2402444, and D2402445. The NDC for the affected package is 16729-452-17. The recall was initiated on August 6, 2026, and is currently ongoing.

Patients and consumers should check their medication bottles for the lot numbers and expiration date listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement therapy. The recall was classified as Class II by the FDA.

The recalled product

Product: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand: LEVOTHYROXINE SODIUM
Manufacturer: ACCORD HEALTHCARE, INC.
Category: Drug — Prescription Drug
Hazard: subpotent-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot #: D2402443
D2402444
D2402445
Exp. Date 10/31/2026.

UPCs (12)

0316729447157
0316729449151
0316729452151
0316729454155
0316729453158
0316729448154
0316729451154
0316729457156
0316729450157
0316729456159
0316729458153
0316729455152

Distribution

Distributed nationwide across the United States.

Same brand · LEVOTHYROXINE SODIUM

Moderate
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
High
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Severe
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
High
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Severe
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02

Same manufacturer · ACCORD HEALTHCARE, INC.

See all →

High
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
High
Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Severe
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02

Same hazard · subpotent drug