Oxandrolone Tablets — Class III drug recall D-1255-2014
Terminated recall by Upsher Smith Laboratories, Inc., reported 2014-04-30, distributed nationwide. Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label
| Recall number | D-1255-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Upsher Smith Laboratories, Inc., Maple Grove, MN, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-04-23 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2014-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,185 bottles |
| Reason classes | labeling |
| NDC | 00245-0272-06 |
| Lot numbers | 2802.042A |
| Expiration dates | 2015-10 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1255-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.