FDA Drug recall D-1178-2023
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-7…
- FDA Drug
- Class III
- terminated
- Published 2023-10-04
On 2023-10-04 the FDA classified a Class III recall of Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-7… by Tolmar, citing superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1178-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-09-12 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tolmar |
| Distribution | US |
Product
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.
Reason
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Identifiers
| ndc | 62935-753-75 |
|---|---|
| ndc | 62935-754-74 |
| ndc | 62935-755-75 |
| ndc | 62935-223-05 |
| ndc | 62935-221-04 |
| ndc | 62935-224-05 |
| ndc | 62935-303-30 |
| ndc | 62935-305-29 |
| ndc | 62935-304-30 |
| ndc | 62935-453-45 |
| ndc | 62935-454-44 |
| ndc | 62935-455-45 |
| code_info | Lot: 13635A1, Exp. 07/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1178-2023%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.