CLASS III Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report

Oxandrolone Tablets, USP, 10 mg recalled by Upsher Smith Laboratories

Upsher Smith Laboratories is recalling Oxandrolone Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 14 Apr 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #2802.042A, Exp. 10/2015

Quantity recalled1,185 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1255-2014
FDA event ID: 68049
Recalling firm: Upsher Smith Laboratories, Maple Grove, MN
Classification: Class III
Status: Terminated
Recall initiated: 14 Apr 2014
FDA classified: 23 Apr 2014
Reported: 30 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Labeling Errors

Timeline

14 Apr 2014	Recall initiated by company
23 Apr 2014	Classified by FDA	+9 days
30 Apr 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is Oxandrolone Tablets, USP, 10 mg recalled?

Yes. Upsher Smith Laboratories recalled Oxandrolone Tablets, USP, 10 mg on 14 Apr 2014. The recall is Class III and its status is Terminated. Recall number D-1255-2014.

Why was it recalled?

Which lots are affected?

Lot #2802.042A, Exp. 10/2015

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Upsher Smith Laboratories

All 6

Reported	Class	Recall	Company	Reason	Where
28 Aug 2019Drug	CLASS II	Bexarotene Capsules, 75 mg recalled by Upsher Smith LaboratoriesBexarotene	Upsher Smith Laboratories	Potency & Assay	4 states
31 Oct 2018Drug	CLASS II	Bumetanide Tablets, USP, 1 mg recalled by Upsher Smith LaboratoriesBumetanide	Upsher Smith Laboratories	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith LaboratoriesBumetanide	Upsher Smith Laboratories	Potency & Assay	Nationwide
20 Feb 2013Drug	CLASS II	Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg recalled	Upsher Smith Laboratories	Potency & Assay	FL, NJ
23 Jan 2013Drug	CLASS III	Divalproex Sodium Delayed-Release Tablets recalled	Upsher Smith Laboratories	Other	Nationwide

Other Oxandrolone recalls

All 2

Reported	Class	Recall	Company	Reason	Where
28 Feb 2018Drug	CLASS II	Oxandrolone USP for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide