CLASS III Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Oxycodone Hydrochloride Tablets, USP 15 mg recalled
Ascent Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets, USP 15 mg, distributed nationwide in the US. The recall was initiated on 22 Jan 2018 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-0248-2018
- FDA event ID
- 78990
- Recalling firm
- Ascent Pharmaceuticals, Central Islip, NY
- Manufacturer
- Camber Pharmaceuticals Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Jan 2018
- FDA classified
- 1 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 22 Jan 2018 | Recall initiated by company | |
| 1 Feb 2018 | Classified by FDA | +10 days |
| 7 Feb 2018 | 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
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Product as listed by the FDA
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Which lots are affected?
Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
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 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 Ascent Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen | Ascent Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled | Ascent Pharmaceuticals | Other | Nationwide |
Other Oxycodone recalls
All 19| 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 II | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 7.5 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 |