FDA Drug recall D-0100-2023
Rifampin Capsules USP, 300 mg, 30-count bottle
- FDA Drug
- Class II
- terminated
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Rifampin Capsules USP, 300 mg, 30-count bottle by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0100-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-12 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
Reason
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Identifiers
| ndc | 68180-658-06 |
|---|---|
| ndc | 68180-658-01 |
| ndc | 68180-659-06 |
| ndc | 68180-659-07 |
| ndc | 68180-659-01 |
| code_info | Lot # A200171, Exp 12/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0100-2023%22
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