FDA Recalls Rifampin Capsules 300mg Nationwide for Subpotency
Lupin Pharmaceuticals recalls Rifampin Capsules USP 300mg nationwide due to subpotency—the drug contains less active ingredient than labeled. Affected lot: A201064, expiring March 2024. 26,352 bottles involved.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a subpotent drug, which represents a risk-of-harm product where therapeutic benefit may not be achieved. While no illnesses have been reported, Rifampin is used to treat serious infections including tuberculosis, and subpotency could result in treatment failure.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Rifampin Capsules USP 300mg in 30-count bottles distributed nationwide within the United States. The affected lot number is A201064 with an expiration date of March 2024. This voluntary recall was initiated by the company on March 21, 2024, and was terminated on April 4, 2025.
The reason for the recall is that the drug has been found to be subpotent, meaning it contains less of the active pharmaceutical ingredient (rifampin) than the labeled amount per capsule. Rifampin is an antibiotic used to treat serious infections, including tuberculosis. Subpotent medication may not provide the intended therapeutic benefit to patients.
The recall affects 26,352 bottles that were distributed nationwide. The product is identified by NDC 6818-0659-06 and was manufactured by Lupin Limited in Aurangabad, India, for Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
Patients currently taking this medication from the affected lot should consult their healthcare provider or pharmacist about whether their supply may be affected and whether a replacement is needed. Healthcare providers should verify lot numbers for their patients' prescriptions.
The recalled product
- Product
- Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- Affected units
- 26,352
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 #: A201064
- Exp. Date March 2024
Distribution
Distributed nationwide across the United States.
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