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

Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

563 recalls, newest first.

Class II · Moderate risk

Budesonide Inhalation Suspension

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

Ongoing Particulate / foreign matter Sun Pharmaceutical Industries INC NDC 47335-633-49 D-0607-2026
Class II · Moderate risk

GSMS Incorporated

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

Ongoing Dissolution failure Golden State Medical Supply Inc. NDC 51407-268-90 D-0587-2026
Class I · High risk

BD ChloraPrep FREPP Clear

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-400-30 D-0625-2026
Class II · Moderate risk

BD ChloraPrep FREPP Clear

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-400-30 D-0623-2026
Class II · Moderate risk

BD ChloraPrep Clear

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-400-31 D-0622-2026
Class II · Moderate risk

TopCare health

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 76162-129-68 D-0579-2026
Class II · Moderate risk

TopCare health

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 76162-128-22 D-0578-2026
Class II · Moderate risk

HyVee

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. D-0572-2026
Class II · Moderate risk

HyVee

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. D-0571-2026
Class II · Moderate risk

Family Wellness

Presence of foreign substance: small metallic particles in chewable tablets.

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 55319-171-68 D-0568-2026

Recalls by year