SigmaPharm Laboratories LLC
Complete recall history across all FDA and CPSC categories — 5 total recalls
SigmaPharm Laboratories LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (5)
FDA drug safety enforcement actions by SigmaPharm Laboratories LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 21, 2021 | Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bot... | Failed Impurities/Degradation Specifications; Out of Specification impurity r... | Class II |
| Aug 13, 2021 | Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laborator... | Failed Impurities Specifications: Out of Specification impurity results obtai... | Class II |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laborato... | Incorrect Product Formulation; product was manufactured with the incorrect Ar... | Class III |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laborator... | Incorrect Product Formulation; product was manufactured with the incorrect Ar... | Class III |
| Apr 22, 2014 | Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 4279... | Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tab... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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