CLASS III Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report
Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled
Boehringer Ingelheim Roxane is recalling Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial, distributed nationwide in the US. The recall was initiated on 28 Jul 2014 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-1486-2014
- FDA event ID
- 68879
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jul 2014
- FDA classified
- 28 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 28 Jul 2014 | Recall initiated by company | |
| 28 Jul 2014 | Classified by FDA | +0 days |
| 6 Aug 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
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
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled?
Yes. Boehringer Ingelheim Roxane recalled Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial on 28 Jul 2014. The recall is Class III and its status is Terminated. Recall number D-1486-2014.
Why was it recalled?
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Which lots are affected?
Lot #: 360241A, Expiry: 05/2015.
Where was it sold?
U.S. 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 21 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 Boehringer Ingelheim Roxane
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|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
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