Pirfenidone recalls

The FDA has published 2 recalls involving Pirfenidone since 2023. The latest was reported on 8 Mar 2023. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

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

Should you stop taking Pirfenidone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.