Hydrocodone Bitartrate recalls
The FDA has published 19 recalls involving Hydrocodone Bitartrate since 2012. The latest was reported on 15 Dec 2021. Most were for potency & assay. Watson Laboratories 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 recalls 19 since 2012
Last 12 months 0 reported
Class I 4 21% of total
Ongoing 1 latest 15 Dec 2021
Recalls per month, last 24 months click a bar for that month Severity split
4 21%9 47%6 32%
Why hydrocodone bitartrate is recalled
Ongoing hydrocodone bitartrate recalls 1 active
All hydrocodone bitartrate recalls, newest first 19 total Reported Class Recall Company Reason Where 15 Dec 2021 Drug CLASS II Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalled Hydrocodone Bitartrate And Acetaminophen Ascent Pharmaceuticals Packaging Defects Nationwide 26 May 2021 Drug CLASS III Hydrocodone Bitartrate and Homatropine Methlybromide recalled Hydrocodone Bitartrate And Homatropine Methylbromide Kvk-Tech Potency & Assay Nationwide 25 Nov 2020 Drug CLASS II Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled Ascent Pharmaceuticals Other Nationwide 20 Nov 2019 Drug CLASS II Hydrocodone Bitartrate and Homatropine Methlybromide Oral recalled Hydrocodone Bitartrate And Homatropine Methylbromide Kvk-Tech Particulate Matter Nationwide 19 Jun 2019 Drug CLASS II Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled Torrent Pharma Sterility Nationwide 19 Jun 2019 Drug CLASS II Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled Torrent Pharma Sterility Nationwide 6 Jun 2018 Drug CLASS III Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg recalled Hydrocodone Bitartrate And Acetaminophen Lupin Somerset Labeling Errors OH 21 Mar 2018 Drug CLASS III Lupin Hydrocodone Bitartrate recalled by Novel Laboratories Hydrocodone Bitartrate And Homatropine Methylbromide Novel Laboratories Potency & Assay Nationwide 20 Sep 2017 Drug CLASS III Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled VistaPharm Labeling Errors Nationwide 8 Feb 2017 Drug CLASS II Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled VistaPharm Sterility Nationwide 5 Feb 2014 Drug CLASS II Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled Watson Laboratories Other Nationwide 22 Jan 2014 Drug CLASS II HYDROcodone Bitartrate/ Acetaminophen Tablet, 7.5 mg/325 mg recalled Aidapak Services Labeling Errors 4 states 25 Sep 2013 Drug CLASS III Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled Watson Laboratories Packaging Defects Nationwide 27 Feb 2013 Drug CLASS I Hydrocodone Bitartrate and Acetaminophen Tablets recalled Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Potency & Assay Nationwide 6 Feb 2013 Drug CLASS I Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg recalled Vintage Pharmaceuticals Potency & Assay Nationwide 28 Nov 2012 Drug CLASS I Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled Vintage Pharmaceuticals Potency & Assay Nationwide 28 Nov 2012 Drug CLASS I Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg recalled Watson Laboratories Potency & Assay Nationwide 8 Aug 2012 Drug CLASS III Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled Mallinckrodt Potency & Assay Nationwide 8 Aug 2012 Drug CLASS II Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled Mallinckrodt Manufacturing (CGMP) Deviations 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.