CLASS III Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report
Oxycodone HCl, Oral Solution USP, 5 mg recalled by West-Ward Columbus
West-Ward Columbus is recalling Oxycodone HCl, Oral Solution USP, 5 mg, distributed nationwide in the US. The recall was initiated on 19 May 2016 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-1441-2016
- FDA event ID
- 74253
- Recalling firm
- West-Ward Columbus, Columbus, OH
- Manufacturer
- Hikma Pharmceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 May 2016
- FDA classified
- 14 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 19 May 2016 | Recall initiated by company | |
| 14 Jul 2016 | Classified by FDA | +56 days |
| 20 Jul 2016 | Published in enforcement report | +6 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 Specification; 9 month stability
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 HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Where it was distributed
Nationwide
Questions about this recall
Is Oxycodone HCl, Oral Solution USP, 5 mg recalled?
Yes. West-Ward Columbus recalled Oxycodone HCl, Oral Solution USP, 5 mg on 19 May 2016. The recall is Class III and its status is Terminated. Recall number D-1441-2016.
Why was it recalled?
Failed Impurities/Degradation Specification; 9 month stability
Which lots are affected?
Lot #560185A; Exp. 6/30/2017
Where was it sold?
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 West-Ward Columbus
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalledMethadone Hydrochloride | West-Ward Columbus | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS III | Leucovorin Calcium Tablets USP, 10 mg recalled by West-Ward ColumbusLeucovorin Calcium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward ColumbusDoxycycline Hyclate | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS III | Ethacrynic Acid Tablets USP, 25 mg recalled by West-Ward Columbus | West-Ward Columbus | Potency & Assay | Nationwide |
Other Oxycodone recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 5 mg recalledOxaydo | Zyla Life Sciences US | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL) recalled | Akorn | Labeling Errors | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg recalledOxycodone Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | NY, OH |