Prescription Rifampin Capsules Recalled for Failed Impurity Specifications
Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.
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: This is an FDA Class II drug recall with no reported illnesses or injuries. The hazard—impurities and degradation discovered during stability testing—represents a potential risk of harm but no actual clinical harm has been reported, placing it in the High category per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Rifampin Capsules USP, 300 mg, distributed nationwide in 30-count bottles (NDC 68180-659-06). The recalled product is Lot #A200171, with an expiration date of 12/2023. Approximately 16,056 bottles were distributed across the United States.
The recall was initiated after the manufacturer discovered failed impurity and degradation specifications during long-term stability testing. Related substance testing revealed failures that do not meet the product's manufacturing specifications.
Patients currently taking Rifampin from the affected lot should contact their healthcare provider or pharmacist before discontinuing or replacing their medication. Healthcare providers and pharmacists should quarantine and return any remaining product from this lot. Medications should not be disposed of in household trash; ask your pharmacy about proper disposal options.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Antibiotic
- Hazard
- impurities
- degradation
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 # A200171
- Exp 12/2023
Distribution
Distributed nationwide across the United States.
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- HighRifampin Capsules Recalled Due to Failed Impurity and Degradation Specification
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- HighPrescription Rifampin Capsules Recalled Due to Failed Quality Specifications
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- ModerateRifampin Capsules Recalled Due to Manufacturing Control Deviation
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