Food, drugs, devices › Upsher Smith Laboratories, Inc.
Drug recall: Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 5
Upsher Smith Laboratories, Inc. (Maple Grove, MN) initiated this drug recall on 14 Apr 2014; FDA lists 1 product record under event 68049, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 1 Jul 2014. Initiation: voluntary: firm initiated. Upsher Smith Laboratories, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Upsher Smith Laboratories, Inc., Maple Grove, MN.
Reason for recall
"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."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1255-2014 | 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 | 1,185 bottles | Class III | Terminated | 30 Apr 2014 |
Context
Other enforcement events for Upsher Smith Laboratories, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Gr | Drug | Class II | 1 |
| 19 Sep 2018 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, M | Drug | Class II | 2 |
| 10 Dec 2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Ma | Drug | Class III | 1 |
| 20 Nov 2012 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith La | Drug | Class II | 1 |
All 5 events for Upsher Smith Laboratories, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.