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Pirfenidone recalls

Pirfenidone products have been recalled 2 times, most recently on 8 Mar 2023. The recalling company is usually Accord Healthcare. The most common reason is manufacturing (cgmp) deviations.

Total recalls2since 2023

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Mar 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why pirfenidone is recalled

Manufacturing (CGMP) Deviations2100%

Companies

Accord Healthcare2100%

By year

20232100%

All pirfenidone recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Drug	CLASS II	Pirfenidone Tablets 801 mg recalled by Accord HealthcarePirfenidone	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Pirfenidone Tablets 267 mg bottle x3/Carton recalledPirfenidone	Accord Healthcare	Manufacturing (CGMP) Deviations	PR

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.