Prescription Drug Recall: Eligard Leuprolide Contains Higher Than Expected Levels
Tolmar, Inc. is recalling Eligard (leuprolide acetate) 7.5 mg monthly injectable suspension nationwide because the constituted product contains higher than expected levels of the active ingredient. The affected lot is 13635A1 with expiration date July 31, 2024.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as a Class III recall, which are typically scored 1 or 2. No illnesses or injuries have been reported in the source. Although the product contains higher than expected levels of active ingredient, the Class III designation indicates the FDA determined that use is not likely to cause adverse health consequences.
Plain-English summary
Tolmar, Inc. is recalling Eligard (leuprolide acetate) for injectable suspension, 7.5 mg monthly. The affected lot is 13635A1 with expiration date July 31, 2024. Approximately 2,990 cartons were distributed nationwide in the United States.
The recall is due to higher than expected levels of leuprolide acetate in the constituted product. Leuprolide acetate is a hormone therapy used to treat certain cancers and gynecological conditions. The elevated drug levels in this batch represent the reason for the recall.
Patients and healthcare providers should be aware of this recall if the affected lot was dispensed or administered. Patients who may have received doses from Lot 13635A1 should discuss this with their healthcare provider.
The recalled product
- Product
- ELIGARD (LEUPROLIDE ACETATE)
- Brand
- ELIGARD
- Manufacturer
- Tolmar, Inc.
- Category
- Drug
- Hazard
- Affected units
- 2,990
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 13635A1
- Exp. 07/31/2024
Distribution
Distributed nationwide across the United States.
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