CLASS II Drug recall · Reported 25 Nov 2020 · FDA Enforcement Report
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled
Ascent Pharmaceuticals is recalling Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg, distributed nationwide in the US. The recall was initiated on 26 Oct 2020 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-0097-2021
- FDA event ID
- 86665
- Recalling firm
- Ascent Pharmaceuticals, Central Islip, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Oct 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 26 Oct 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +22 days |
| 25 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Product as listed by the FDA
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled?
Yes. Ascent Pharmaceuticals recalled Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg on 26 Oct 2020. The recall is Class II and its status is Terminated. Recall number D-0097-2021.
Why was it recalled?
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Which lots are affected?
Lot #: 20070518, Exp. Date June 2022
Where was it sold?
Nationwide within the United States
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 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 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 III | Oxycodone Hydrochloride Tablets, USP 15 mg recalledOxycodone Hydrochloride | Ascent Pharmaceuticals | Other | Nationwide |
Other Hydrocodone bitartrate and acetaminophen recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | VistaPharm | Labeling Errors | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS I | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Potency & Assay | Nationwide |