Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Liothyronine Sodium Tablets Recalled for Impurities

Agency Publication Date: December 14, 2023

Summary

Sun Pharmaceutical Industries Inc. has voluntarily recalled 96,192 bottles of Liothyronine Sodium Tablets (5 mcg, 100-count bottle). Liothyronine Sodium is a medication used to treat hypothyroidism. This recall was issued because the tablets failed to meet required specifications for impurities and degradation during testing. No incidents or injuries have been reported to date regarding this issue.

Risk

Degraded medication or the presence of impurities may result in the drug being less effective than intended. This could potentially affect the treatment of thyroid conditions by failing to provide the expected dose of the active medication.

What You Should Do

This recall affects Liothyronine Sodium Tablets, USP 5 mcg, sold in 100-count bottles with NDC 62756-589-88 and distributed by Sun Pharmaceutical Industries, Inc.
Check your medication for the following affected lot numbers: DND0059A, DND0060A, DND0061A (Exp 12/2023), DND0062A, DND0063A, DND0064A, DND0065A, DND0180A, DND0181A, DND0182A, DND0183A, DND0184A (Exp 01/2024), or DND0597A (Exp 02/2024).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Liothyronine Sodium Tablets, USP 5 mcg (100-count bottle)by Sun Pharmaceutical Industries, Inc.

Variants: 5 mcg, Tablet, 100-count bottle

Lot Numbers:

DND0059A (Exp 12/2023)

DND0060A (Exp 12/2023)

DND0061A (Exp 12/2023)

DND0062A (Exp 01/2024)

DND0063A (Exp 01/2024)

DND0064A (Exp 01/2024)

DND0065A (Exp 01/2024)

DND0180A (Exp 01/2024)

DND0181A (Exp 01/2024)

DND0182A (Exp 01/2024)

DND0183A (Exp 01/2024)

DND0184A (Exp 01/2024)

DND0597A (Exp 02/2024)

NDC:

62756-589-88

Rx Only. Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93542

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 96,192 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Liothyronine Sodium Tablets, USP 5 mcg, sold in 100-count bottles with NDC 62756-589-88 and distributed by Sun Pharmaceutical Industries, Inc.

Check your medication for the following affected lot numbers: DND0059A, DND0060A, DND0061A (Exp 12/2023), DND0062A, DND0063A, DND0064A, DND0065A, DND0180A, DND0181A, DND0182A, DND0183A, DND0184A (Exp 01/2024), or DND0597A (Exp 02/2024).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Liothyronine Sodium Tablets, USP 5 mcg (100-count bottle)by Sun Pharmaceutical Industries, Inc.

Variants: 5 mcg, Tablet, 100-count bottle

Lot Numbers:

DND0059A (Exp 12/2023)

DND0060A (Exp 12/2023)

DND0061A (Exp 12/2023)

DND0062A (Exp 01/2024)

DND0063A (Exp 01/2024)

DND0064A (Exp 01/2024)

DND0065A (Exp 01/2024)

DND0180A (Exp 01/2024)

DND0181A (Exp 01/2024)

DND0182A (Exp 01/2024)

DND0183A (Exp 01/2024)

DND0184A (Exp 01/2024)

DND0597A (Exp 02/2024)

NDC:

62756-589-88

Rx Only. Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ.