The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 4, 2026
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 4, 2026
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Haleon US Holdings LLC · Jun 4, 2026
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Amneal Pharmaceuticals, LLC · Jun 3, 2026
Microbial Contamination of Non-Sterile Products
BEEKEEPER'S NATURALS USA INC. · Jun 1, 2026
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Ascend Laboratories, LLC · Jun 1, 2026
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.
Golden State Medical Supply Inc. · May 29, 2026
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
SUN PHARMACEUTICAL INDUSTRIES INC · May 29, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Lannett Company Inc. · May 27, 2026
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
Microbial contamination of sterile products
Zep Inc · May 22, 2026
Failed Stability Specifications
AbbVie Inc. · May 18, 2026
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Eugia US LLC · May 18, 2026
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA Inc. · May 14, 2026
Failed Impurities/Degradations Specifications
Fresenius Kabi USA, LLC · May 14, 2026
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
AVEVA Drug Delivery Systems, Inc. · May 14, 2026
Showing the 40 most recent recalls of 1617 tracked.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.