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

FDA Drug Recall #D-0150-2024 - Class II, December 4, 2023

Recall Summary

Recall Number D-0150-2024
Classification Class II - Moderate risk
Date Initiated December 4, 2023
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SUN PHARMACEUTICAL INDUSTRIES INC
Location Princeton, NJ
Product Type Drugs
Quantity 96,192 bottles

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

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide

Lot / 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

Other Recalls from SUN PHARMACEUTICAL INDUSTRIES INC

Recall # Classification Product Date
D-0628-2026 Class II Perampanel CIII Tablets, 6mg, Rx only, 30 Table... Jun 17, 2026
D-0654-2026 Class III Fexofenadine Hydrochloride Tablets, USP 180 mg,... Jun 1, 2026
D-0607-2026 Class II Budesonide Inhalation Suspension, 1mg/2mL, 30 x... May 29, 2026
D-0598-2026 Class II Xyvona (levorphanol tartrate tablets), 2mg, 100... May 22, 2026
D-0599-2026 Class II Xyvona (levorphanol tartrate tablets), 3mg, 100... May 22, 2026

Frequently Asked Questions

Nitrosamines are probable human carcinogens, they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.