CLASS III Drug recall · Reported 21 Mar 2018 · FDA Enforcement Report
Lupin Hydrocodone Bitartrate recalled by Novel Laboratories
Novel Laboratories is recalling Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg, distributed nationwide in the US. The recall was initiated on 5 Mar 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-0599-2018
- FDA event ID
- 79298
- Recalling firm
- Novel Laboratories, Somerset, NJ
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 14 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 14 Mar 2018 | Classified by FDA | +9 days |
| 21 Mar 2018 | Published in enforcement report | +7 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 Specifications
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
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
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 Novel Laboratories
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|---|---|---|---|---|---|
| Drug | CLASS III | Fluocinolone Acetonide Topical Solution recalled by Novel LaboratoriesFluocinolone Acetonide | Novel Laboratories | Other | Nationwide |
| Drug | CLASS III | Famotidine for Oral Suspension, USP 40 mg recalled by Novel LaboratoriesFamotidine | Novel Laboratories | Potency & Assay | Nationwide |
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 |