Upsher Smith Laboratories recalls
FDA enforcement reports naming Upsher Smith Laboratories, Inc. as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Aug 28, 2019
- Aug 28, 2019Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-…Drug · Upsher Smith Laboratories, Inc.Failed Dissolution SpecificationsClass II
- Oct 31, 2018Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith…Drug · Upsher Smith Laboratories, Inc.Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.Class II
- Oct 31, 2018Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith…Drug · Upsher Smith Laboratories, Inc.Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.Class II
- Apr 30, 2014Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Ups…Drug · Upsher Smith Laboratories, Inc.Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the co…Class III
- Feb 20, 2013Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only,…Drug · Upsher Smith Laboratories, Inc.Failed Dissolution Test RequirementsClass II
- Jan 23, 2013Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-coun…Drug · Upsher Smith Laboratories, Inc.Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.Class III