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Upsher Smith Laboratories, Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20132
20141
20182
20191
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FDA Recall Terminated Historical recordClass II

Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00

by Upsher Smith Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
August 28, 2019
Distribution
Multiple states

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FDA Recall Terminated Historical recordClass II

Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

by Upsher Smith Laboratories, Inc.

Reason
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Published
October 31, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11

by Upsher Smith Laboratories, Inc.

Reason
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Published
October 31, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06

by Upsher Smith Laboratories, Inc.

Reason
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 correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9

by Upsher Smith Laboratories, Inc.

Reason
Failed Dissolution Test Requirements
Published
February 20, 2013
Distribution
FL, NJ.

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FDA Recall Terminated Historical recordClass III

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.

by Upsher Smith Laboratories, Inc.

Reason
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Published
January 23, 2013
Distribution
Nationwide

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Showing 1–6 of 6 results

This page lists recalls that name Upsher Smith Laboratories, Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.