Rifampin Capsules USP
Subpotent Drug
Yes — there is an active recall. 4 ongoing FDA recalls mention Rifampin (23 total). Check the affected lots below.
Most common reason: Impurity / degradation (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Rifampin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Subpotent Drug
Failed Impurities/Degradation Specification.
Subpotent Drug and Failed Impurities/Degradation Specifications
Subpotent Drug and Failed Impurities/Degradation Specifications
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Failed Impurities/Degradations Specifications
Failed Impurities/Degradation specifications
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Subpotent drug: low fill volume in some of the capsules
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
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