UnratedDrug recall · FDA · Published April 7, 2022
Mylan Rifampin Injection Recall: Impurities May Cause Harm
Mylan recalls Rifampin injections due to impurities found in stability testing. Affected lots expire Dec 2022 to Apr 2023. Stop using if you have these specific lots.
Mylan is recalling Rifampin injections that may contain impurities from stability testing. This could pose a risk to patients using the medication. The recall affects specific production lots with expiration dates from December 2022 through April 2023. Read more at govinfonow.com/recall/34971-mylan-rifampin-injection-recall-impurities-may-cause-harm.
“Mylan Rifampin Injection Recall: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34971-mylan-rifampin-injection-recall-impurities-may-cause-harm. Based on FDA recall #D-0774-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0774-2022%22&limit=1).
The FDA announced on April 7, 2022, that Mylan Pharmaceuticals Inc. voluntarily recalled Rifampin for Injection due to failed impurity specifications. The recall affects 33,893 vials distributed nationwide.
The recall was initiated because high out-of-specification results were obtained for related compounds during stability testing. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Mylan Pharmaceuticals Inc. has 54 other recalls on record since June 28, 2012. Other recent recalls of similar products include Sagent Busulfan Injection Recall (May 4, 2026), Somerset Therapeutics Dexamethasone Injection Recall (Feb. 4, 2026), and Lupin Ganirelix Acetate Injection Recall (Nov. 13, 2025).
How to tell if you have this one
Check the lot number on the vial label. The affected lots are 7008990 (expiring Dec 2022), 7009025 (expiring Feb 2023), 7009085 and 7009086 (expiring Apr 2023).
Brand
Mylan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the vial label to determine if it is one of the affected lots.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0774-2022 (April 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0774-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.