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

560 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

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