CLASS II Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
Rifampin Capsules USP 300mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Rifampin Capsules USP 300mg. The recall was initiated on 5 Jan 2024 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-0284-2024
- FDA event ID
- 93753
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Rifampin
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2024
- FDA classified
- 30 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Jan 2024 | Recall initiated by company | |
| 30 Jan 2024 | Classified by FDA | +25 days |
| 7 Feb 2024 | 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
Subpotent Drug and Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Questions about this recall
Why was it recalled?
Subpotent Drug and Failed Impurities/Degradation Specifications
Which lots are affected?
A200817 exp 1/2024
Where was it sold?
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
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.
Other products in this recall event
1 other product · FDA event 93753This product is part of a recall event; the main page for the event is Rifampin Capsules USP 150mg recalled by Lupin Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
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, 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 |
| Drug | CLASS II | Rifampin Capsules USP, 300 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |