Eligard — Class III drug recall D-1178-2023
Terminated recall by Tolmar, Inc., reported 2023-10-04, distributed nationwide. Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
| Recall number | D-1178-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tolmar, Inc., Fort Collins, CO, United States |
| Recall initiated | 2023-09-12 |
| Classified | 2023-09-27 |
| Reported by FDA | 2023-10-04 |
| Terminated | 2024-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,990 cartons |
| Reason classes | potency |
| NDC | 62935-0221-04, 62935-0223, 62935-0223-05, 62935-0224-05, 62935-0303, 62935-0303-30, 62935-0304-30, 62935-0305-29, 62935-0453, 62935-0453-45, 62935-0454-44, 62935-0455-45, 62935-0753, 62935-0753-75, 62935-0754-74, 62935-0755-75 |
| Lot numbers | 13635A1 |
| Expiration dates | 2024-07-31 |
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 for recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
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-1178-2023. 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.