CLASS II Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Liothyronine Sodium Tablets, USP 5 mcg recalled
SigmaPharm Laboratories is recalling Liothyronine Sodium Tablets, USP 5 mcg, distributed nationwide in the US. The recall was initiated on 22 Apr 2014 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-1344-2014
- FDA event ID
- 68123
- Recalling firm
- SigmaPharm Laboratories, Bensalem, PA
- Brand
- Liothyronine Sodium
- Manufacturer
- SIGMAPHARM LABORATORIES, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2014
- FDA classified
- 21 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Thyroid Medication
Timeline
| 22 Apr 2014 | Recall initiated by company | |
| 21 May 2014 | Classified by FDA | +29 days |
| 28 May 2014 | 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
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Product as listed by the FDA
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Liothyronine Sodium Tablets, USP 5 mcg recalled?
Yes. SigmaPharm Laboratories recalled Liothyronine Sodium Tablets, USP 5 mcg on 22 Apr 2014. The recall is Class II and its status is Terminated. Recall number D-1344-2014.
Why was it recalled?
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Which lots are affected?
Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015
Where was it sold?
Nationwide and Puerto Rico
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SigmaPharm Laboratories
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 10 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
Other Liothyronine recalls
All 7| 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, 25 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 USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 25 mcg recalled by Mayne Pharma | Mayne Pharma | Potency & Assay | Nationwide |