Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Rifampin Capsules USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
68180-0659-06
Compare with the code on your package — it is the most precise check available.
Drug: Rifampin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| rifampin NDC 68180-0659 |
300 mg/1 | Capsule Oral |
Lupin Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-659-06
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0100-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Rifampin recalls
See all
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradation Specification.
Class II · Moderate risk
Rifampin Capsules USP 300mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rifampin Capsules USP 150mg
Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rifampin Capsules USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Lupin Pharmaceuticals Inc.
All 2022 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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