Mycophenolic Acid Delayed-Release Tablets USP recall
FDA recall D-0668-2024 · initiated Sep 3, 2024
Ascend Laboratories, LLC recalled Mycophenolic Acid Delayed-Release Tablets USP in Sep 2024 — an FDA Class II recall (D-0668-2024) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 117,493 bottles
Details
- Product
- 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.
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and PR
- Initiated
- Sep 3, 2024
- FDA report date
- Oct 2, 2024
Frequently asked
- Was Mycophenolic Acid Delayed-Release Tablets USP recalled?
- Ascend Laboratories, LLC recalled Mycophenolic Acid Delayed-Release Tablets USP in Sep 2024 — an FDA Class II recall (D-0668-2024) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Mycophenolic Acid Delayed-Release Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0668-2024 was: Failed Dissolution Specifications
- Is a recalled Mycophenolic Acid Delayed-Release Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Mycophenolic Acid Delayed-Release Tablets USP are affected?
- Distributed: Nationwide in the USA and PR. The recall covers these lots — 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, 23122…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0668-2024.