Frovatriptan Succinate tablets recalled for manufacturing process deviations
Glenmark Pharmaceuticals is voluntarily recalling Frovatriptan Succinate 2.5mg tablets due to manufacturing process deviations. Affected lots were distributed nationwide; patients should contact their pharmacy or healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall, indicating potential for serious health consequences from manufacturing deviations. However, no illnesses or injuries have been reported in the source, and the specific nature of the CGMP deviation is not detailed. This supports a High severity rating rather than Severe.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Frovatriptan Succinate Tablets 2.5mg in 9-count bottles (NDC# 68462-694-97). The affected lots are #17231352 (expiration June 2025) and #17231649 (expiration July 2025). These tablets were distributed nationwide across the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. The FDA has classified this as a Class II recall, which indicates that serious adverse health consequences or death is possible but not probable. This is a voluntary, firm-initiated recall.
Patients taking Frovatriptan Succinate from the affected lots should not abruptly discontinue their medication without consulting their healthcare provider or pharmacist. Contact your pharmacy to determine if your prescription is from one of the recalled lots. If your medication is affected, work with your healthcare provider to obtain replacement doses. Return any recalled product to your pharmacy.
The recalled product
- Product
- FROVATRIPTAN SUCCINATE (FROVATRIPTAN SUCCINATE)
- Brand
- FROVATRIPTAN SUCCINATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription tablet
- Hazard
- manufacturing-defect
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 (3)
- Lot # 17231352
- exp. date Jun-25 17231649
- exp. date Jul-25
Distribution
Distributed nationwide across the United States.
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