Tolmar Eligard injection recall: Higher leuprolide acetate levels risk
Tolmar recalls Eligard (leuprolide acetate) injections due to higher than expected leuprolide acetate levels in the reconstituted product. This may cause serious side effects. Affected units have NDC 62935-753-75 and lot 13635A1.
Use caution until it’s fixed
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Contact the company
What happened, in plain English
Tolmar is recalling Eligard injections because they contain higher than expected levels of leuprolide acetate after reconstitution. This could lead to serious side effects if used as directed. People with a prescription for this medication should check if they have the recalled batch. Read more at govinfonow.com/recall/33131-tolmar-eligard-injection-recall-higher-leuprolide-acetate-levels-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33131-tolmar-eligard-injection-recall-higher-leuprolide-acetate-levels-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-1178-2023
Cite this page
“Tolmar Eligard injection recall: Higher leuprolide acetate levels risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33131-tolmar-eligard-injection-recall-higher-leuprolide-acetate-levels-risk. Based on FDA recall #D-1178-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1178-2023%22&limit=1).
Why it’s dangerous
The product contains higher than expected levels of leuprolide acetate after being reconstituted. This can cause serious side effects like severe pain, swelling, or other adverse reactions when injected.
Who’s affected
People with a prescription for Eligard injections (7.5 mg monthly) are affected. Those who have the specific NDC 62935-753-75 and lot 13635A1 are at highest risk.
How to tell if you have this one
Check the product label for NDC 62935-753-75 and lot number 13635A1. Eligard is a prescription-only injectable medication that must be reconstituted before use.
- Brand
Tolmar- Category
Drug
What to do — step by step
Check Product Label
Look for NDC 62935-753-75 and lot number 13635A1 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1178-2023 (September 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1178-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.