Reported Oct 2, 2024 · Ongoing

Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem…

Ascend Laboratories, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707

Is this the product you have?

  • Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Lot codes and dates
    • Lots 22123437
    • 22123438
    • 22123535
    • Exp Date 9/30/24
    • 22123536
    • 22123537
    • 22123538
    • 22123646
    • 22123647
    • Exp Date 10/31/24
    • 23120529
    • 23120530
    • Exp Date 1/31/25
    • 23120703
    • 23120705
    • Exp Date 2/28/25
    • 23121429
    • 23121726
    • 23122049
    • 23122097
    • Exp Date
    • 4/30/25
    • 23121984
    • 23121985
    • 23121986
    • Exp Date 5/31/25
    • 23122325
    • 23122329
    • 23122330
    • 23122331
    • Exp Date 6/30/26
    • 23122776
    • 23122852
    • 23122853
    • 23123154
    • 23123155
    • Exp Date 8/31/26
    • 23123458
    • Exp Date 9/30/26
Amount recalled
117,493 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ascend Laboratories, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.