Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

62 recalls · Class III, newest first

Class III · Low risk

Sodium Chloride Ophthalmic Ointment USP

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

Terminated Particulate / foreign matter Akorn, Inc. NDC 17478-622-35 D-0859-2020
Class III · Low risk

Benazepril HCl Tablets

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Terminated Particulate / foreign matter Amneal Pharmaceuticals, Inc. NDC 65162-754-10 D-0134-2020
Class III · Low risk

Carvedilol Tablets

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

Terminated Particulate / foreign matter Zydus Pharmaceuticals USA Inc NDC 68382-092-05 D-1242-2019
Class III · Low risk

Fenofibrate Tablets

Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

Terminated Particulate / foreign matter Hetero Labs, Ltd. - Unit III NDC 31722-596-90 D-1211-2018
Class III · Low risk

Auryxia (ferric citrate)

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

Terminated Particulate / foreign matter Keryx Biopharmaceuticals, Inc. NDC 59922-631-01 D-0133-2018
Class III · Low risk

Mefenamic Acid Capsules

Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules

Terminated Particulate / foreign matter Shionogi Inc. NDC 66993-070-30 D-0219-2018
Class III · Low risk

Amlodipine Besylate Tablet

PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

Terminated Particulate / foreign matter Ascend Laboratories LLC NDC 67877-199-10 D-1134-2017
Class III · Low risk

Pentasa (mesalamine)

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Terminated Particulate / foreign matter Shire PLC NDC 54092-189-81 D-0432-2017
Class III · Low risk

Telmisartan Tablets

Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

Terminated Particulate / foreign matter Torrent Pharmaceuticals Limited NDC 13668-158-72 D-0824-2016

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