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Rifampin Capsules USP 150mg recall

FDA recall D-0283-2024 · initiated Jan 5, 2024

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Feb 7, 2024How we research

Lupin Pharmaceuticals Inc. recalled Rifampin Capsules USP 150mg in Jan 2024 — an FDA Class II recall (D-0283-2024) 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.

A200816 exp 1/2024 A201248 exp 3/2024

Quantity recalled: 15,576 Bottles

Details

Product
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
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
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Rifampin Capsules USP 150mg recalled?
Lupin Pharmaceuticals Inc. recalled Rifampin Capsules USP 150mg in Jan 2024 — an FDA Class II recall (D-0283-2024) 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 150mg recalled?
Per the FDA enforcement record, the reason for recall D-0283-2024 was: Subpotent Drug and Failed Impurities/Degradation Specifications
Is a recalled Rifampin Capsules USP 150mg 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 150mg 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 — A200816 exp 1/2024 A201248 exp 3/2024. 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-0283-2024.

Source: openFDA Drug Enforcement record D-0283-2024

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