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Upsher-Smith Laboratories

Generic drug maker in United States. FDA records under 4 spellings of its name, each linked to the record.

  • Drug applications: 89
  • Drug recalls: 6
  • 510(k) clearances: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Jul 29, 2019Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC:Class II · Failed Dissolution SpecificationsDrug recalls
Sep 19, 2018Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0Class II · Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.Drug recalls
Sep 19, 2018Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0Class II · Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.Drug recalls
Apr 14, 2014Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: PharmaceutClass III · Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the botDrug recalls
Dec 10, 2012Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by UpsherClass III · Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primaryDrug recalls
Nov 20, 2012Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc MinnClass II · Failed Dissolution Test RequirementsDrug recalls
May 16, 1988CONDOM-MATE VAGINAL LUBRICANTK881338 · KMJ510(k) clearances

Names and Identifiers

Appears as
UPSHER SMITH LABSUpsher Smith Laboratories, Inc.Upsher-Smith Laboratories, Inc.UPSHER SMITH

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.