Agency classClass IIOur severity:Severe FDA (Drugs)·D-0786-2026·Announced 2026-09-02

Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide

Accord Healthcare is voluntarily recalling Levothyroxine Sodium 300 mcg tablets because they may contain less active ingredient than labeled.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect involves a critical therapeutic parameter like potency in a maintenance medication.

Plain-English summary

Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles. The recall is due to the product being subpotent, meaning it may contain less active ingredient than stated on the label. The affected product is identified by Lot # D2402337 with an expiration date of 10/31/2026, and NDC 16729-458-15.

The product was distributed nationwide within the United States. It was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc. The recall was initiated on August 6, 2026, and is currently ongoing. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients taking this medication should contact their healthcare provider for guidance on alternative treatment options. Consumers should not take the recalled product and should return it to the pharmacy where it was purchased or contact Accord Healthcare for further instructions.

The recalled product

Product: LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand: LEVOTHYROXINE SODIUM
Manufacturer: ACCORD HEALTHCARE, INC.
Category: Drug — Prescription Medication
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 (2)

Lot #: D2402337
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

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

Same manufacturer · ACCORD HEALTHCARE, INC.

See all →

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

Same hazard · subpotent drug