Drug recalls

FDA enforcement reports from the last 12 months · Class I is the most serious. Type in the filter box to search, click a column to sort, or toggle whether bulk API / for-further-processing products are included.

ⓘ How this was built

Data sources

openFDA drug enforcement reports (FDA)

Method

Rows are FDA's own enforcement records, ingested daily; classifications and dates are FDA's. Filtering and counting only — no modeling.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

All classes Class I (27)Class II (623)Class III (64)·1y 2y 5y


II	Mirabegron D-0745-2026	Zydus Pharmaceuticals (USA) Inc	CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.	Aug 5, 2026	Ongoing
II	Diovan D-0746-2026	Novartis Pharmaceuticals Corporation	Failed Dissolution Specifications	Aug 4, 2026	Ongoing
II	— D-0759-2026	Shoolin Pharma Chem LLP	CGMP Deviations:Noted during FDA inspection	Aug 3, 2026	Ongoing
II	— D-0760-2026	Shoolin Pharma Chem LLP	CGMP Deviations:Noted during FDA inspection	Aug 3, 2026	Ongoing
II	— D-0763-2026	Shoolin Pharma Chem LLP	CGMP Deviations:Noted during FDA inspection	Aug 3, 2026	Ongoing
II	— D-0762-2026	Shoolin Pharma Chem LLP	CGMP Deviations:Noted during FDA inspection	Aug 3, 2026	Ongoing
II	— D-0761-2026	Shoolin Pharma Chem LLP	CGMP Deviations:Noted during FDA inspection	Aug 3, 2026	Ongoing
I	Optiray 350 D-0773-2026	Liebel-Flarsheim Company LLC	Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.	Jul 31, 2026	Ongoing
II	clindamycin palmitate hydrochloride D-0768-2026	Heritage Pharmaceuticals Inc	Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.	Jul 30, 2026	Ongoing
II	— D-0753-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	Clear Eyes Maximum Itchy Eye Relief D-0766-2026	Prestige Brands Holdings	Lack of assurance of sterility. The recall is due to potential contamination	Jul 29, 2026	Ongoing
II	— D-0747-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0749-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0755-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0751-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0748-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0750-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0756-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0752-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing
II	— D-0757-2026	Apollo Care, LLC	Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Jul 29, 2026	Ongoing

Source: FDA drug enforcement reports (openFDA) · showing 20 of 711 recalls