Food, drugs, devices › Lupin Pharmaceuticals Inc.
Drug recall: Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland
Lupin Pharmaceuticals Inc. (Baltimore, MD) initiated this drug recall on 5 Jan 2024; FDA lists 2 product records under event 93753, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Terminated, terminated 27 Aug 2024. Initiation: voluntary: firm initiated. Lupin Pharmaceuticals Inc. has 91 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD.
Reason for recall
"Subpotent Drug and Failed Impurities/Degradation Specifications"
Distribution
"Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0283-2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06 | 15,576 Bottles | Class II | Terminated | 7 Feb 2024 |
| D-0284-2024 | 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 | 165,60 bottles | Class II | Terminated | 7 Feb 2024 |
Context
Other enforcement events for Lupin Pharmaceuticals Inc.
All 91 events for Lupin Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug and Failed Impurities/Degradation Specifications"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.