The Recall Desk
HighFDA (Drugs)·D-0283-2024·Announced 2024-02-07

Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures

Lupin Pharmaceuticals recalled 15,576 bottles of Rifampin antibiotic capsules due to subpotency and failed quality specifications. The affected lots did not meet pharmaceutical standards for drug strength and purity.

What this means for you

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 of a subpotent antibiotic with failed quality specifications. While no illnesses or injuries have been reported, the product presents a risk-of-harm as subpotent rifampin could fail to treat infections effectively. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Lupin Pharmaceuticals initiated a recall of Rifampin (Rifampin) Capsules USP 150mg distributed under FDA recall number D-0283-2024. Approximately 15,576 bottles with lot codes A200816 (expiration 1/2024) and A201248 (expiration 3/2024) were affected.

The recall was initiated due to subpotency and failed impurities/degradation specifications. The recalled lots did not meet pharmaceutical standards for drug strength and quality, which could affect therapeutic effectiveness.

The affected medication was distributed through 32 wholesale/distributor accounts to 156 distribution sites. The affected product is Rifampin Capsules USP 150mg, NDC 68180-658-06, manufactured for Lupin Pharmaceuticals Inc. (Baltimore, Maryland) by Lupin Limited (Aurangabad, India).

Patients taking Rifampin from the affected lots should consult with their healthcare provider before discontinuing or changing their medication. Healthcare providers and pharmacies should verify lot numbers against the recall and arrange for replacement product.

The recalled product

Product
RIFAMPIN (RIFAMPIN)
Brand
RIFAMPIN
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug
Hazard
Affected units
15,576

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 (1)

  • A200816 exp 1/2024 A201248 exp 3/2024

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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