Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures
Lupin Pharmaceuticals recalled 15,576 bottles of Rifampin antibiotic capsules due to subpotency and failed quality specifications. The affected lots did not meet pharmaceutical standards for drug strength and purity.
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 recall of a subpotent antibiotic with failed quality specifications. While no illnesses or injuries have been reported, the product presents a risk-of-harm as subpotent rifampin could fail to treat infections effectively. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Lupin Pharmaceuticals initiated a recall of Rifampin (Rifampin) Capsules USP 150mg distributed under FDA recall number D-0283-2024. Approximately 15,576 bottles with lot codes A200816 (expiration 1/2024) and A201248 (expiration 3/2024) were affected.
The recall was initiated due to subpotency and failed impurities/degradation specifications. The recalled lots did not meet pharmaceutical standards for drug strength and quality, which could affect therapeutic effectiveness.
The affected medication was distributed through 32 wholesale/distributor accounts to 156 distribution sites. The affected product is Rifampin Capsules USP 150mg, NDC 68180-658-06, manufactured for Lupin Pharmaceuticals Inc. (Baltimore, Maryland) by Lupin Limited (Aurangabad, India).
Patients taking Rifampin from the affected lots should consult with their healthcare provider before discontinuing or changing their medication. Healthcare providers and pharmacies should verify lot numbers against the recall and arrange for replacement product.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug
- Hazard
- subpotency
- impurity
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 (1)
- A200816 exp 1/2024 A201248 exp 3/2024
Distribution
Distribution scope not specified by the agency.
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- HighRifampin Antibiotic Capsules Recalled for Subpotency and Failed Specifications
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- HighPrescription Rifampin Capsules Recalled Due to Failed Quality Specifications
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- HighPrescription Rifampin Capsules Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-01-18
- ModerateRifampin Capsules Recalled Due to Manufacturing Control Deviation
FDA (Drugs) · 2022-08-24
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