Hydrocodone Bitartrate recalls
The FDA has published 5 recalls involving Hydrocodone Bitartrate since 2018. The latest was reported on 15 Dec 2021. Most were for potency & assay. KVK-Tech has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls5since 2018
Last 12 months0reported
Class I00% of total
Ongoing0latest 15 Dec 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 40%Class III 3 60%
Why hydrocodone bitartrate is recalled
Companies
Brands
By year
All hydrocodone bitartrate recalls, newest first
5 total| 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 Homatropine Methlybromide Oral recalledHydrocodone Bitartrate And Homatropine Methylbromide | KVK-Tech | Particulate Matter | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen | Lupin Somerset | Labeling Errors | OH |
| Drug | CLASS III | Lupin Hydrocodone Bitartrate recalled by Novel LaboratoriesHydrocodone Bitartrate And Homatropine Methylbromide | Novel Laboratories | Potency & Assay | Nationwide |
Should you stop taking Hydrocodone Bitartrate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.