FDA Drug Recalls

Recalls / Active ingredient / Hydrocodone Bitartrate

Hydrocodone Bitartrate

6 FDA drug recalls involving the active ingredient “Hydrocodone Bitartrate”.

DateClassProductFirm
2021-11-19Class IIHydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured foAscent Pharmaceuticals, Inc.
2021-04-27Class IIIHydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, MfdKVK-Tech, Inc.
2019-11-01Class IIHydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx onKVK-Tech, Inc.
2019-07-11Class IIHydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydroTris Pharma Inc.
2018-05-24Class IIIHydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured byLUPIN SOMERSET
2018-03-05Class IIILupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets ManufacturNovel Laboratories, Inc.