Rifampin recalls: 9 FDA reports
Recalls involving Rifampin. What was wrong with each batch, and how the FDA graded the risk.
9Reports
0Class I
0Ongoing
2024-02-07Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimo
D-0283-2024 · Class II · reported 2024-02-07 · Terminated
- Why it was recalled
- Subpotent Drug and Failed Impurities/Degradation Specifications
- Product
- 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
- Where it went
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- How much
- 15,576 Bottles
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American H
D-0285-2024 · Class II · reported 2024-02-07 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specification.
- Product
- Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
- Where it went
- Nationwide in the USA
- How much
- 1,568 cartons
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimor
D-0284-2024 · Class II · reported 2024-02-07 · Terminated
- Why it was recalled
- Subpotent Drug and Failed Impurities/Degradation Specifications
- Product
- 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 went
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- How much
- 165,60 bottles
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Pac
D-0165-2023 · Class II · reported 2023-01-25 · Terminated
- Why it was recalled
- Failed Impurities/Degradations Specifications
- Product
- Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)
- Where it went
- Nationwide in the USA.
- How much
- 3,091 cartons
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Ma
D-0100-2023 · Class II · reported 2023-01-18 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
- 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
- Where it went
- Distributed Nationwide in the USA
- How much
- 16,056 30 count bottles
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc.,
D-1343-2022 · Class II · reported 2022-08-24 · Terminated
- Why it was recalled
- CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- Product
- 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 went
- Product was distributed nationwide.
- How much
- 7,872/30 count bottles
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional
D-0774-2022 · Class II · reported 2022-04-27 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
- Product
- Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
- Where it went
- Nationwide in the USA
- How much
- 33,893 vials
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61
D-0139-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
- Product
- Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
- Where it went
- Nationwide in the USA
- How much
- 19,165 vials
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporat
D-1234-2015 · Class II · reported 2015-07-22 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
- Product
- Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
- Where it went
- Nationwide,Hawaii, and Puerto Rico
- How much
- 7,593 vials
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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