Rifampin Capsules USP 300mg recall
FDA recall D-0284-2024 · initiated Jan 5, 2024
Lupin Pharmaceuticals Inc. recalled Rifampin Capsules USP 300mg in Jan 2024 — an FDA Class II recall (D-0284-2024) because Subpotent Drug and Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug and Failed Impurities/Degradation Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 165,60 bottles
Details
- Product
- Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- Initiated
- Jan 5, 2024
- FDA report date
- Feb 7, 2024
Frequently asked
- Was Rifampin Capsules USP 300mg recalled?
- Lupin Pharmaceuticals Inc. recalled Rifampin Capsules USP 300mg in Jan 2024 — an FDA Class II recall (D-0284-2024) because Subpotent Drug and Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rifampin Capsules USP 300mg recalled?
- Per the FDA enforcement record, the reason for recall D-0284-2024 was: Subpotent Drug and Failed Impurities/Degradation Specifications
- Is a recalled Rifampin Capsules USP 300mg 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 300mg are affected?
- Distributed: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.. The recall covers these lots — A200817 exp 1/2024. 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-0284-2024.