Upsher-SmithLaboratories, LLC
NDC labeler code: 0832
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 20, 1998 | ANDA074726 | Potassium chloride KLOR-CON M10, KLOR-CON M15, KLOR-CON M20 | Upsher Smith Labs |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2021
-
March 15, 2021 · Class II · Terminated · D-0592-2021 · Amantadine
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00
-
March 15, 2021 · Class II · Terminated · D-0593-2021 · Haloperidol
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11
2019
-
July 29, 2019 · Class II · Terminated · D-1836-2019 · Bexarotene
Failed Dissolution Specifications
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026