Medications & Supplements/Prescription Drugs

Liothyronine Sodium Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: November 1, 2023

Summary

Sun Pharmaceutical Industries Inc. has recalled 9,696 bottles of Liothyronine Sodium Tablets, USP, a prescription medication used to treat hypothyroidism. The recall involves 100-count bottles of both 5 mcg and 25 mcg strengths that failed quality testing for impurities and degradation. Using medication that does not meet established purity standards could potentially impact the treatment's effectiveness or safety. No incidents or injuries have been reported to date.

Risk

The tablets failed to meet required specifications for impurities and degradation. This means the chemical composition of the drug changed over time, which can lead to reduced potency or the presence of unwanted substances that could cause unexpected health effects.

What You Should Do

This recall affects Liothyronine Sodium Tablets, USP, in 5 mcg and 25 mcg strengths, sold in 100-count bottles under the Sun Pharmaceutical Industries brand.
Identify affected 5 mcg bottles by checking for NDC 62756-589-88 and lot number DND0058A with an expiration date of 12/2023.
Identify affected 25 mcg bottles by checking for NDC 62756-590-88 and lot number DNC2204A with an expiration date of 11/2023.
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 Sun Pharmaceutical Industries Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more 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)

Variants: 5 mcg, 100-count bottle, Rx only

Lot Numbers:

DND0058A (Exp. 12/2023)

NDC:

62756-589-88

Recall #: D-0083-2024; Quantity: 7392 Bottles

Product: Liothyronine Sodium Tablets, USP (25 mcg)

Variants: 25 mcg, 100-count bottle, Rx only

Lot Numbers:

DNC2204A (Exp. 11/2023)

NDC:

62756-590-88

Recall #: D-0084-2024; Quantity: 2304 Bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93256

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: pharmacies nationwide

Manufactured In: India, United States

Units Affected: 2 products (7392 Bottles; 2304 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, in 5 mcg and 25 mcg strengths, sold in 100-count bottles under the Sun Pharmaceutical Industries brand.

Identify affected 5 mcg bottles by checking for NDC 62756-589-88 and lot number DND0058A with an expiration date of 12/2023.

Identify affected 25 mcg bottles by checking for NDC 62756-590-88 and lot number DNC2204A with an expiration date of 11/2023.

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 Sun Pharmaceutical Industries Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more 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)

Variants: 5 mcg, 100-count bottle, Rx only

Lot Numbers:

DND0058A (Exp. 12/2023)

NDC:

62756-589-88

Recall #: D-0083-2024; Quantity: 7392 Bottles

Product: Liothyronine Sodium Tablets, USP (25 mcg)

Variants: 25 mcg, 100-count bottle, Rx only

Lot Numbers:

DNC2204A (Exp. 11/2023)

NDC:

62756-590-88

Recall #: D-0084-2024; Quantity: 2304 Bottles