Upsher Smith Recalls Oxandrolone Tablets Due to Missing Primary Labels
Upsher Smith Laboratories is recalling 36 bottles of Oxandrolone Tablets, USP, 10 mg, because they were packaged without primary labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to missing primary labels on a small number of bottles.
Plain-English summary
Upsher Smith Laboratories, Inc. is recalling 36 bottles of Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottles (NDC 0245-0272-06). The recall involves Lot #2802.042A, which has an expiration date of 10/2015. The affected product was manufactured by Pharmaceutics International, Inc., for Upsher-Smith Labs.
The recall was initiated because three cases of the product, totaling 36 bottles, were packaged without the primary label on the bottle. Although the bottles lacked primary labels, they were packaged in the correct finished product shipper, labeled with the correct shipper bar code label, and sealed with tamper-evident tape. These cases were erroneously shipped to Upsher-Smith.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers with this specific lot of Oxandrolone Tablets should contact their pharmacist or Upsher Smith Laboratories for further instructions.
The recalled product
- 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
- Manufacturer
- Upsher Smith Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #2802.042A
- Exp. 10/2015
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Upsher Smith Laboratories, Inc.
See all →- ModerateUpsher-Smith Recalls Bexarotene Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-08-28
- SevereUpsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product
FDA (Drugs) · 2018-10-31
- ModerateUpsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product
FDA (Drugs) · 2018-10-31
- ModerateUpsher Smith Recalls Propranolol Hydrochloride Capsules for Dissolution Failure
FDA (Drugs) · 2013-02-20
- LowUpsher Smith Recalls Divalproex Sodium Tablets Due to Labeling Error
FDA (Drugs) · 2013-01-23
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02