Skip to content
Product safetyFDAUnited StatesImports

Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction

7 October 2026

In plain English

FDA corrects its September 13, 2023 notice to add that ANDAs referencing Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were also withdrawn for safety or effectiveness reasons.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
7 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 13, 2023 (88 FR 62799). The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The notice did not include the determination that the abbreviated new drug applications (ANDAs) referencing Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were also determined to be wit
The full text is at the source

Olive tells you which of these hit your products.

Olive reads every change like these against your own products, codes and trade lanes, whether you import, export or both, and drafts the update to your compliance program for your approval. Nothing changes without you.

Get startedLive demo

Olivra lists official notices for information only. It is not legal advice, and Olive is not a lawyer or a licensed customs broker. The official text at the source is what counts.

More from FDA

See everything Olive monitors