SigmaPharm Recalls Liothyronine Sodium Tablets Due to Cross-Contamination
SigmaPharm is recalling four lots of Liothyronine Sodium Tablets 5 mcg due to potential cross-contamination with trace amounts of a previously manufactured product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential carryover of trace amounts without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
SigmaPharm Laboratories LLC is recalling four lots of Liothyronine Sodium Tablets, USP 5 mcg. The recall was initiated because of the finding of a potential carryover of trace amounts of a previously manufactured product.
The affected product is a prescription-only medication available in 100-count bottles (NDC 42794-018-02) and 1000-count bottles (NDC 42794-018-06). The specific lots involved are 1302201 (Exp 01/2015), 1305501 (Exp 03/2015), 1314801 (Exp 10/2015), and 1302202 (Exp 01/2015). A total of 43,007 bottles were distributed nationwide and in Puerto Rico.
Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
- Brand
- LIOTHYRONINE SODIUM
- Manufacturer
- SigmaPharm Laboratories LLC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 43,007
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s: a) 1302201
- Exp 01/2015
- 1305501
- Exp 03/2015
- 1314801
- Exp 10/2015
- b) 1302202
UPCs (3)
- 0342794018121
- 0342794019128
- 0342794020124
Distribution
Related recalls
Same brand · LIOTHYRONINE SODIUM
- ModerateLiothyronine Sodium tablets recalled due to failed impurity and degradation specifications
FDA (Drugs) · 2023-12-20
- HighLiothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications
FDA (Drugs) · 2023-11-08
- HighLiothyronine Sodium Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-11-08
Same manufacturer · SigmaPharm Laboratories LLC
See all →- ModerateSodium Phenylbutyrate Powder Recalled for Impurity Specification Failures
FDA (Drugs) · 2021-10-06
- ModerateSodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications
FDA (Drugs) · 2021-09-01
- LowSigmaPharm Recalls Asenapine Tablets Due to Incorrect Flavoring Agent
FDA (Drugs) · 2021-05-26
- LowSigmaPharm Recalls Asenapine Tablets Due to Incorrect Flavoring Agent
FDA (Drugs) · 2021-05-26
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- HighLiothyronine Sodium Tablets Recalled for Potential Labeling Mixup
FDA (Drugs) · 2014-01-29
- ModerateLiothyronine Sodium Tablets Recalled for Potential Labeling Error
FDA (Drugs) · 2014-01-22
- HighLiothyronine Sodium Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-11-08
- HighLiothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications
FDA (Drugs) · 2023-11-08
- LowLiothyronine Sodium Tablets Recalled for Failed Stability Testing
FDA (Drugs) · 2013-05-15
- ModerateSandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination
FDA (Drugs) · 2018-04-25