CLASS II Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
Rifampin Capsules, USP, 150 mg HDPE recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Rifampin Capsules, USP, 150 mg HDPE, distributed nationwide in the US. The recall was initiated on 28 Jul 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1343-2022
- FDA event ID
- 90616
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Rifampin
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2022
- FDA classified
- 16 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 28 Jul 2022 | Recall initiated by company | |
| 16 Aug 2022 | Classified by FDA | +19 days |
| 24 Aug 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Which lots are affected?
Lot #A200170, exp. date December 2023
Where was it sold?
Product was distributed nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Rifampin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rifampin Capsules USP, 300mg recalled by Lupin Pharmaceuticals | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Rifampin Capsules USP 300mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
| Drug | CLASS II | Rifampin Capsules USP, 150 mg doses recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
| Drug | CLASS II | Rifampin Capsules USP, 150 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |