Rifampin Capsules USP recall
FDA recall D-0285-2024 · initiated Jan 11, 2024
Amerisource Health Services LLC recalled Rifampin Capsules USP in Jan 2024 — an FDA Class II recall (D-0285-2024) because Failed Impurities/Degradation Specification.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specification.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,568 cartons
Details
- Product
- Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 11, 2024
- FDA report date
- Feb 7, 2024
Frequently asked
- Was Rifampin Capsules USP recalled?
- Amerisource Health Services LLC recalled Rifampin Capsules USP in Jan 2024 — an FDA Class II recall (D-0285-2024) because Failed Impurities/Degradation Specification. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rifampin Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0285-2024 was: Failed Impurities/Degradation Specification.
- Is a recalled Rifampin Capsules USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Rifampin Capsules USP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 1008111, Exp. Date 01/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0285-2024.