Rizatriptan Benzoate Orally Disintegrating Tablets Recalled for Out-of-Specification Impurities
Macleods Pharma USA is recalling Rizatriptan Benzoate 10mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing of controlled samples.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with out-of-specification test results in organic impurities—a manufacturing or quality-control issue with no reported patient harm or direct safety threat. Per the severity rubric, FDA Class III recalls are typically scored 1 or 2, and this one involves only analytical findings without evidence of actual harm.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Rizatriptan Benzoate Orally Disintegrating Tablets 10mg (18-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.
The affected product includes 643,800 blister packs (888,336 tablets) with lot numbers BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, and BRM2116A, with expiration dates of 04/2025. The product is manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India, and distributed by Macleods Pharma USA Inc. in Plainsboro, New Jersey.
Patients taking this medication should consult their healthcare provider or pharmacist before stopping use or switching to an alternative. Healthcare providers should contact their suppliers regarding product replacement or credit. Consumers should not discard medication without first consulting a healthcare professional or local pharmacy for proper disposal instructions.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- MACLEODS PHARMA USA, INC
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 (7)
- Lot #: BRM2111A
- BRM2112A
- BRM2113A
- BRM2114A
- BRM2115A
- BRM2116A
- exp. date 04/2025
UPCs (6)
- 0333342094452
- 0333342094414
- 0333342094469
- 0333342094520
- 0333342093455
- 0333342093417
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by MACLEODS PHARMA USA, INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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Same hazard · out of specification impurities
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FDA (Drugs) · 2021-11-03
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