Upsher Smith Laboratories, Inc.
Complete recall history across all FDA and CPSC categories — 6 total recalls
Upsher Smith Laboratories, Inc. 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 (6)
FDA drug safety enforcement actions by Upsher Smith Laboratories, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 29, 2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured fo... | Failed Dissolution Specifications | Class II |
| Sep 19, 2018 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: U... | Failed impurities/ degradation specifications: Product is Out of Specificatio... | Class II |
| Sep 19, 2018 | Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: U... | Failed impurities/ degradation specifications: Product is Out of Specificatio... | Class II |
| Apr 14, 2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufacture... | Labeling: Missing Label; Three cases of product (total of 36 bottles) were pa... | Class III |
| Dec 10, 2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity... | Labeling: Label Error On Declared Strength; Some bottles of product were miss... | Class III |
| Nov 20, 2012 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules... | Failed Dissolution Test Requirements | 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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