Mycophenolic Acid recalls

The FDA has published 3 recalls involving Mycophenolic Acid since 2014. The latest was reported on 2 Oct 2024. Most were for potency & assay. Ascend Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 2 Oct 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why mycophenolic acid is recalled

Potency & Assay267%
Labeling Errors133%

Companies

By year

2024133%
2015133%
2014133%

Ongoing mycophenolic acid recalls

1 active

Reported	Class	Recall	Company	Reason	Where
2 Oct 2024Drug	CLASS II	Mycophenolic Acid Delayed-Release Tablets USP, 360 mg recalledMycophenolic Acid	Ascend Laboratories	Potency & Assay	Nationwide

All mycophenolic acid recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
2 Oct 2024Drug	CLASS II	Mycophenolic Acid Delayed-Release Tablets USP, 360 mg recalledMycophenolic Acid	Ascend Laboratories	Potency & Assay	Nationwide
10 Jun 2015Drug	CLASS II	Mycophenolic Acid Delayed-release Tablets, 180 mg recalled by Mylan Lab	Mylan Lab	Potency & Assay	Nationwide
29 Jan 2014Drug	CLASS II	Mycophenolic Acid DR, Tablet, 180 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Mycophenolic Acid?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.