Liothyronine Sodium Tablet
FDA Recall NDC 62756-591
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Liothyronine Sodium (NDC 62756-591). A significant event, classified as Class II, was initiated on Dec 04, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2023 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Dec 04, 2023
Dec 20, 2023
96,192 bottles
Recall Profile & Regulatory Data
Event ID
93542
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 21, 2025
Product Description
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
Batch or Lot Expiration Information
Lot# Lot DND0059A Expires 12/2023 Lot DND0060A Expires 12/2023 Lot DND0061A Expires 12/2023 Lot DND0062A Expires 01/2024 Lot DND0063A Expires 01/2024 Lot DND0064A Expires 01/2024 Lot DND0065A Expires 01/2024 Lot DND0180A Expires 01/2024 Lot DND0181A Expires 01/2024 Lot DND0182A Expires 01/2024 Lot DND0183A Expires 01/2024 Lot DND0184A Expires 01/2024 Lot DND0597A Expires 02/2024
Affected Packages Involved in this Recall
62756-589-83Product
62756-589-01Product
62756-589-88Product
62756-589-08Product
62756-589-18Product
62756-590-83Product
62756-590-01Product
62756-590-88Product
62756-590-08Product
62756-590-18Product
62756-591-83Product
62756-591-01Product
62756-591-88Product
62756-591-08Product
62756-591-18Product
October 2023 Class II Recall: Failed Impurities/Degradation Specifications.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications.
Oct 20, 2023
Nov 08, 2023
7392 Bottles
Recall Profile & Regulatory Data
Event ID
93256
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jul 25, 2024
Product Description
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88
Batch or Lot Expiration Information
Lot# : DND0058A, Exp. Date 12/2023
Affected Packages Involved in this Recall
62756-589-83Product
62756-589-01Product
62756-589-88Product
62756-589-08Product
62756-589-18Product
62756-590-83Product
62756-590-01Product
62756-590-88Product
62756-590-08Product
62756-590-18Product
62756-591-83Product
62756-591-01Product
62756-591-88Product
62756-591-08Product
62756-591-18Product
October 2023 Class II Recall: Failed Impurities/Degradation Specifications.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications.
Oct 20, 2023
Nov 08, 2023
2304 Bottles
Recall Profile & Regulatory Data
Event ID
93256
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jul 25, 2024
Product Description
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88
Batch or Lot Expiration Information
Lot# : DNC2204A, Exp. Date 11/2023
Affected Packages Involved in this Recall
62756-589-83Product
62756-589-01Product
62756-589-88Product
62756-589-08Product
62756-589-18Product
62756-590-83Product
62756-590-01Product
62756-590-88Product
62756-590-08Product
62756-590-18Product
62756-591-83Product
62756-591-01Product
62756-591-88Product
62756-591-08Product
62756-591-18Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
