CLASS II Drug recall · Reported 27 Apr 2022 · FDA Enforcement Report
Rifampin for Injection, USP, 600 mg/vial, One Vial recalled
Mylan Pharmaceuticals is recalling Rifampin for Injection, USP, 600 mg/vial, One Vial per, distributed nationwide in the US. The recall was initiated on 7 Apr 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0774-2022
- FDA event ID
- 89910
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- Rifampin
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2022
- FDA classified
- 15 Apr 2022
- Reported
- 27 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Apr 2022 | Recall initiated by company | |
| 15 Apr 2022 | Classified by FDA | +8 days |
| 27 Apr 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Which lots are affected?
Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Rifampin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rifampin Capsules USP, 300mg recalled by Lupin Pharmaceuticals | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Rifampin Capsules USP 300mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
| Drug | CLASS II | Rifampin Capsules USP, 150 mg doses recalledRifampin | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin | Lupin Pharmaceuticals | Potency & Assay | MD |
| Drug | CLASS II | Rifampin Capsules USP, 150 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |