FDA Drug recall D-0018-2026
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67… by Ascend Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0018-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-19 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 67877-511-90 |
|---|---|
| ndc | 67877-511-05 |
| ndc | 67877-511-10 |
| ndc | 67877-511-55 |
| ndc | 67877-511-33 |
| ndc | 67877-511-38 |
| ndc | 67877-512-90 |
| ndc | 67877-512-05 |
| ndc | 67877-512-10 |
| ndc | 67877-512-44 |
| ndc | 67877-512-33 |
| ndc | 67877-512-38 |
| ndc | 67877-513-90 |
| ndc | 67877-513-05 |
| ndc | 67877-513-10 |
| ndc | 67877-513-23 |
| ndc | 67877-513-33 |
| ndc | 67877-513-38 |
| ndc | 67877-514-90 |
| ndc | 67877-514-05 |
| ndc | 67877-514-10 |
| ndc | 67877-514-33 |
| ndc | 67877-514-38 |
| code_info | Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0018-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.