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All product recalls associated with Akorn, Inc..
Total Recalls
1000
Past Year
730
Class I (Serious)
175
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Canned shrimp may be under-processed
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
This recall involves three cart base models: WT42 "Tuffy" plastic cart; W42/AVJ42/SS-AVJ42 metal cart; and LP-DUO/TPDUOEQ plastic cart. The WT42 "Tuffy" is a 3-shelf plastic cart sold under the brand name H. Wilson "Tuffy" in a variety of colors with different color suffixes after the "WT42" prefix in the item number. The carts have a plastic handle with a logo that reads "the Tuffy" in the center. The W42/AVJ42/SS-AVJ42 cart is 3-shelf adjustable height metal cart. It is also sold under the model number AVJ42 with either a Luxor or H. Wilson logo on the front center of the top shelf, and under the model number SS-AVJ42 with a LineLeader logo on the front center of the top shelf. It is sold in a variety of colors with different color suffixes after the "W42" or "AVJ42" prefixes in the item number. The LP-DUO/TPDUOEQ cart is a 3-shelf adjustable height plastic cart with a push handle on the top shelf. The Luxor logo is stamped on the center of the handle and is a black/dark gray color. Please see below for a chart containing a list of recalled cart models. AV42 LP42LPE-B WT42BUE-B/WTD WT42ORE-N/WTD WTPS42BYME-N AV42B LPDUO-B WT42BUE-N WT42OW WTPS42E-B AVJ42 LPDUOBW-B WT42BUE-N/WTD WT42OW-B WTPS42E-N AVJ42-BY LPDUOE-B WT42BUE/WTD WT42OWBE WTPS42E-P AVJ42-CH LPDUOEBW-B WT42BUNH-B WT42OWE WTPS42G-N AVJ42-GN LPDUOENL-B WT42BY WT42OWE-B WTPS42GE AVJ42-OW LPLDUO-B WT42BY-B WT42P WTPS42GE-B AVJ42-P LPLDUOE-B WT42BY-N WT42P-B WTPS42GE-N AVJ42-RB SS-AVJ42 WT42BYBE WT42P-N WTPS42GYE AVJ42-RD SS-AVJ42-LKB WT42BYE WT42PB WTPS42GYE-B AVJ42-T SS-AVJ42-LKBDL WT42BYE-B WT42PE WTPS42GYE-N AVJ42-U SS-AVJ42KB WT42BYE-B/WTD WT42PE-B WTPS42GYME-B AVJ42-YW SS-AVJ42KB+EPS WT42BYE-N WT42PE-B/WTD WTPS42GYME-N AVJ42-Z SS-AVJ42KB+LAP WT42BYE-N/WTD WT42PE-N WTPS42HG-N AVJ42/C5I SS-AVJ42KB+MM1G WT42BYE/WTD WT42PE-N/WTD WTPS42HGE AVJ42B SS-AVJ42KB+MM2C WT42BYME-N/WTD WT42PE/WTD WTPS42HGE-N AVJ42B-GN SS-AVJ42KB2 WT42BYME/WTD WT42R WTPS42ME-B AVJ42B-RB SS-AVJ42KBDL WT42E WT42R-B WTPS42ME-N AVJ42B-RD SUDMC-42-BK WT42E-B/WTD WT42R-B/WTD WTPS42ORE-B AVJ42B-YW SUDMC-42-RB WT42E-N WT42R-N WTPS42OWE AVJ42BKBDL SUDMC-42-RD WT42E-N/WTD WT42RBE WTPS42OWE-B AVJ42DL SUDMC-42-YW WT42E-P WT42RE WTPS42OWME-B AVJ42DL-RB SUDMC-42DL-BK WT42E-P/WTD WT42RE-B WTPS42P-B AVJ42DL-RD SUDMC-42KB-BK WT42G WT42RE-B/WTD WTPS42PE AVJ42DL-YW SUDMC-42KB-RB WT42G-B WT42RE-N WTPS42PE-B AVJ42KB SUDMC-42KB-RD WT42G-N WT42RNH-B WTPS42PE-N AVJ42KB-BY SUDMC-42KB-YW WT42GBE WT42S WTPS42PME AVJ42KB-CH SUDMC-42KBDL-BK WT42GE WT42TN WTPS42PME-B AVJ42KB-GN SUDMC-42KBDL-RB WT42GE-B WT42TN-B WTPS42PME-N AVJ42KB-LG W42A WT42GE-B/WTD WT42TN-B/WTD WTPS42R-B AVJ42KB-OW W42ABU WT42GE-N WT42TNE WTPS42RE-B AVJ42KB-P W42ABUE WT42GME-B/WTD WT42TNE-B WTPS42RE-N AVJ42KB-RB W42ABUEKB WT42GY WT42TNE-N WTPS42RME-B AVJ42KB-RB/WFSB W42ABUEKBDL WT42GY-B WT42Y WTPS42RME-N AVJ42KB-RD W42ABYEKB WT42GY-B/WTD WT42Y-B WTPS42YE-B AVJ42KB-RD/WFSB W42AE WT42GY-N WT42Y-B/WTD WTPS42YME-N AVJ42KB-T W42AEKB WT42GYBE WT42Y-N WTPS42Z-N AVJ42KB-WH W42AEKBDL WT42GYE WT42YE WTPS42ZE AVJ42KB-WH+2MM W42AG WT42GYE-B WT42YE-B WTPS42ZE-B AVJ42KB-WH+MLAP W42AGE WT42GYE-B/WTD WT42YE-N WTPS42ZE-N AVJ42KB-YW W42AGEKB WT42GYE-N WT42YE/WTD WTPS42ZME AVJ42KB-Z W42AKB WT42GYE-N/WTD WT42Z WTPS42ZME-B AVJ42KB/WFSB W42AR WT42GYE/WTD WT42Z-B WTPS42ZME-N AVJ42KBDL W42ARE WT42GYME-N/WTD WT42Z-B/WTD WTPSLP42BYE-B AVJ42KBDL-BY W42AREKB WT42HG WT42Z-N WTPSLP42BYE-N AVJ42KBDL-GN W42AREKBDL WT42HG-B WT42ZE WTPSLP42E-B AVJ42KBDL-LG W42AY WT42HG-N WT42ZE-B WTPSLP42E-N AVJ42KBDL-RB W42AYE WT42HGE WT42ZE-B/WTD WTPSLP42GE-N AVJ42KBDL-RB/M W42AYEKB WT42HGE-B WT42ZE-N WTPSLP42GYE AVJ42KBDL-RD W42E WT42HGE-B/WTD WT42ZE-N/WTD WTPSLP42PE AVJ42KBDL-YW WT42 WT42HGE-N WT42ZME-B/WTD WTPSLP42PE-B AVJ42KBDL/WFSB WT42-B/WTD WT42ME WT42ZME/WTD WTPSLP42PE-N AVJ42KBN WT42-N WT42ME-B/WTD WTPS42-B WTPSLP42RE-N AVJ42N WT42-P WT42ME-N/WTD WTPS42-BASE WTPSLP42ZE AVJ42N-BY WT42-P/WTD WT42ME-P/WTD WTPS42-N WTPSLP42ZE-B AVJ42N-GN WT42/WTD WT42NH WTPS42-P WTPSLP42ZE-N AVJ42N-OW WT42B WT42NHR-B WTPS42BU-N WTPSP42-B AVJ42N-RB WT42BE WT42OR WTPS42BUE WTPSP42BUE LP42-B WT42BU WT42OR-B WTPS42BUE-B WTPSP42BUE-N LP42BW-B WT42BU-B WT42OR-B/WTD WTPS42BUE-N WTPSP42E-B LP42E-B WT42BU-B/WTD WT42OR-N WTPS42BUME-N WTPSP42E-N LP42EBW-B WT42BU-N WT42ORE WTPS42BY-B WTPSP42E-P LP42LE-B WT42BUBE WT42ORE-B WTPS42BY-N WTPSP42ZE LP42LE-B-FLUTE WT42BUE WT42ORE-B/WTD WTPS42BYE-B WTPSP42ZE-B LP42LP-B WT42BUE-B WT42ORE-N WTPS42BYE-N WTPSP42ZE-N
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
May contain undeclared milk
May contain undeclared milk
May contain undeclared milk
May contain undeclared milk