Rizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities
Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.
What this means for you
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: This is an FDA Class III recall involving out-of-specification test results for organic impurities. No illnesses, injuries, or adverse events are reported in the source text, and the hazard remains theoretical. Per the rubric, Class III recalls with no reported harm are typically scored 1 or 2; a precautionary quality/manufacturing defect warrants a score of 2.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Rizatriptan Benzoate Orally Disintegrating Tablets 5mg (12-tablet blister packs) distributed nationwide in the United States. The recall was initiated due to out-of-specification test results obtained during organic impurities testing of controlled samples.
Affected lots include BRL2102A and BRL2103A, with an expiration date of 04/2025. Approximately 13,260 blister packs (238,680 tablets) are involved in this recall. The product carries NDC 33342-093-41 and was manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India, for Macleods Pharma USA Inc. in Plainsboro, NJ.
Consumers who have purchased this medication should contact their pharmacy or healthcare provider for guidance. Patients should not discontinue their migraine medication without consulting their physician, as abrupt cessation could affect their treatment. Healthcare providers should check their inventory and quarantine affected lots immediately.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- MACLEODS PHARMA USA, INC
- Hazard
- out-of-specification-impurities
- organic-impurities
- 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 #: BRL2102A
- BRL2103A
- exp. date 04/2025
UPCs (6)
- 0333342094452
- 0333342094414
- 0333342094469
- 0333342094520
- 0333342093455
- 0333342093417
Distribution
Distributed nationwide across the United States.
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