CLASS III Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
Rifampin For Injection USP, 600 mg*/vial recalled by Akorn
Akorn is recalling Rifampin For Injection USP, 600 mg*/vial, distributed nationwide in the US. The recall was initiated on 20 Aug 2015 and the FDA has classified it as Class III.
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-0231-2016
- FDA event ID
- 72192
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Aug 2015
- FDA classified
- 13 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Aug 2015 | Recall initiated by company | |
| 13 Nov 2015 | Classified by FDA | +85 days |
| 25 Nov 2015 | 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 Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
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, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Where it was distributed
US: Nationwide
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Which lots are affected?
Lot #: 14RIF1(A), Expiry: 9/30/2016.
Where was it sold?
US: Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Akorn
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | 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 recalled | 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 |