Mycophenolic Acid Delayed-Release Tablets USP — Class II drug recall D-0668-2024
Ongoing recall by Ascend Laboratories, LLC, reported 2024-10-02, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0668-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2024-09-03 |
| Classified | 2024-09-24 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 117,493 bottles |
| Reason classes | specification failure |
| NDC | 67877-0426, 67877-0426-05, 67877-0426-12, 67877-0426-33, 67877-0426-38, 67877-0427, 67877-0427-05, 67877-0427-12, 67877-0427-33, 67877-0427-38 |
| Lot numbers | 22123437, 22123438, 22123535, 22123536, 22123537, 22123538, 22123646, 22123647, 23120529, 23120530, 23120703, 23120705, 23121429, 23121726, 23121984, 23121985, 23121986, 23122049, 23122097, 23122325, 23122329, 23122330, 23122331, 23122776, 23122852, 23122853, 23123154, 23123155, 23123458 |
| Expiration dates | 2024-09-30, 2024-10-31, 2025-01-31, 2025-02-28, 2025-04-30, 2025-05-31, 2026-06-30, 2026-08-31, 2026-09-30 |
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.
Reason for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0668-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.