CLASS III Drug recall · Reported 4 Oct 2023 · FDA Enforcement Report
Eligard (leuprolide acetate) for injectable suspension recalled
Tolmar is recalling Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, distributed nationwide in the US. The recall was initiated on 12 Sep 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1178-2023
- FDA event ID
- 93044
- Recalling firm
- Tolmar, Fort Collins, CO
- Brand
- Eligard
- Manufacturer
- TOLMAR Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Sep 2023
- FDA classified
- 27 Sep 2023
- Reported
- 4 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Sep 2023 | Recall initiated by company | |
| 27 Sep 2023 | Classified by FDA | +15 days |
| 4 Oct 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it recalled?
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Which lots are affected?
Lot: 13635A1, Exp. 07/31/2024
Where was it sold?
Nationwide in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tolmar
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|---|---|---|---|---|---|
| Drug | CLASS II | Naftifine Hydrochloride Gel recalled by Tolmar | Tolmar | Potency & Assay | KY |
| Drug | CLASS II | Clindamycin and Benzoyl Peroxide Gel, 1%/5% recalled by TOLMAR | Tolmar | Potency & Assay | Nationwide |
| Drug | CLASS III | Ketoconazole Shampoo recalled by Tolmar | Tolmar | Potency & Assay | Nationwide |
Other Leuprolide recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leuprolide 50 mcg/ Micro Lupron Kit, Compounded Rx recalled | Perry Drug | Sterility | KS, MO |
| Drug | CLASS II | Lupron Depot (Leuprolide Acetate recalled by AbbVieLupron Depot | AbbVie | Other | Nationwide |
| Drug | CLASS II | Lupron Depot-ped (Leuprolide Acetate recalled by AbbVieLupron Depot-ped | AbbVie | Other | Nationwide |
| Drug | CLASS II | Lupron Depot (leuprolide acetate recalled by AbbVieLupron Depot | AbbVie | Other | Nationwide |
| Drug | CLASS II | Lupron Depot (Leuprolide Acetate recalled by AbbVieLupron Depot | AbbVie | Other | Nationwide |