CLASS III Drug recall · Reported 6 Jun 2018 · FDA Enforcement Report
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg recalled
Lupin Somerset is recalling Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, distributed in Ohio. The recall was initiated on 24 May 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-0836-2018
- FDA event ID
- 80187
- Recalling firm
- Lupin Somerset, Somerset, NJ
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 May 2018
- FDA classified
- 31 May 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 24 May 2018 | Recall initiated by company | |
| 31 May 2018 | Classified by FDA | +7 days |
| 6 Jun 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: Missing Label
Product as listed by the FDA
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Where it was distributed
OH
Questions about this recall
Why was it recalled?
Labeling: Missing Label
Which lots are affected?
Lot # S800257; Exp. 01/20
Where was it sold?
OH
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.
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| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
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Other Hydrocodone Bitartrate recalls
All 19| 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 | 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 |