CLASS II Drug recall · Reported 8 Nov 2023 · FDA Enforcement Report
Liothyronine Sodium Tablets, USP, 25 mcg recalled
SUN Pharmaceutical Industries is recalling Liothyronine Sodium Tablets, USP, 25 mcg, distributed nationwide in the US. The recall was initiated on 20 Oct 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0084-2024
- FDA event ID
- 93256
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Liothyronine Sodium
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2023
- FDA classified
- 1 Nov 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 20 Oct 2023 | Recall initiated by company | |
| 1 Nov 2023 | Classified by FDA | +12 days |
| 8 Nov 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: DNC2204A, Exp. Date 11/2023
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93256This product is part of a recall event; the main page for the event is Liothyronine Sodium Tablets, USP, 5 mcg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Liothyronine Sodium Tablets, USP, 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Liothyronine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP, 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 25 mcg recalled by Mayne Pharma | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SigmaPharm Laboratories | Other | Nationwide |
| Drug | CLASS II | Liothyronine Sodium, Tablet, 25 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |