CLASS II ONGOING Drug recall · Reported 2 Oct 2024 · FDA Enforcement Report

Mycophenolic Acid Delayed-Release Tablets USP, 360 mg recalled

Ascend Laboratories is recalling Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, distributed nationwide in the US. The recall was initiated on 3 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 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.

NDC67877-426, 67877-427

UPC0367877427126

Quantity recalled117,493 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0668-2024
FDA event ID: 95275
Recalling firm: Ascend Laboratories, Parsippany, NJ
Brand: Mycophenolic Acid
Manufacturer: Ascend Laboratories, LLC
Classification: Class II
Status: Ongoing
Recall initiated: 3 Sep 2024
FDA classified: 24 Sep 2024
Reported: 2 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

3 Sep 2024	Recall initiated by company
24 Sep 2024	Classified by FDA	+21 days
2 Oct 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA and PR

Nationwide Puerto Rico

Questions about this recall

Is Mycophenolic Acid Delayed-Release Tablets USP, 360 mg recalled?

Yes. Ascend Laboratories recalled Mycophenolic Acid Delayed-Release Tablets USP, 360 mg on 3 Sep 2024. The recall is Class II and its status is Ongoing. Recall number D-0668-2024.

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

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.

Where was it sold?

Nationwide in the USA and PR

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Mycophenolic Acid recalls

All 2

Reported	Class	Recall	Company	Reason	Where
10 Jun 2015Drug	CLASS II	Mycophenolic Acid Delayed-release Tablets, 180 mg recalled by Mylan Lab	Mylan Lab	Potency & Assay	Nationwide