CLASS II Drug recall · Reported 15 Dec 2021 · FDA Enforcement Report
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalled
Ascent Pharmaceuticals is recalling Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, distributed nationwide in the US. The recall was initiated on 19 Nov 2021 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-0276-2022
- FDA event ID
- 89060
- Recalling firm
- Ascent Pharmaceuticals, Central Islip, NY
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2021
- FDA classified
- 7 Dec 2021
- Reported
- 15 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 19 Nov 2021 | Recall initiated by company | |
| 7 Dec 2021 | Classified by FDA | +18 days |
| 15 Dec 2021 | 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
Product Mix-up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Product Mix-up
Which lots are affected?
Lot #: 21070817, Exp 6/2023
Where was it sold?
USA 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 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 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/325mg recalled | Ascent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride Tablets, USP 15 mg recalledOxycodone Hydrochloride | Ascent Pharmaceuticals | Other | Nationwide |
Other Hydrocodone Bitartrate recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled | Ascent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Homatropine Methlybromide Oral recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled | Torrent Pharma | Sterility | Nationwide |