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Class II: temporary or reversible health riskTerminated

Sun Pharmaceutical Industries Liothyronine Sodium Tablets Recall

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun…

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Risk level
Class II
Reported by FDA
Dec 20, 2023
Recall ID
D-0150-2024
Check your lot numberHow we source this data

Summary

Sun Pharmaceutical Industries recalled Liothyronine Sodium Tablets starting Dec 4, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0150-2024 on Dec 20, 2023. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0150-2024
Classification
Class II
Status
Terminated
Recall initiated
Dec 4, 2023
FDA report date
Dec 20, 2023
Quantity
96,192 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC

Original FDA data

Every field from FDA enforcement report D-0150-2024, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
93542
Address
2 Independence Way
Code information
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
Postal code
08540-6620
Report date
Dec 20, 2023
Product type
Drugs
Recall number
D-0150-2024
Classification
Class II
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product quantity
96,192 bottles
Termination date
Mar 21, 2025
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Dec 4, 2023
Initial firm notification
Letter
Center classification date
Dec 14, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0150-2024, published Dec 20, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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