Pirfenidone Tablets Recalled Due to Manufacturing Compliance Deviations
Accord Healthcare is recalling Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, Puerto Rico, and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall initiated due to manufacturing facility compliance deviations identified during inspection. No illnesses or injuries have been reported. The recall is precautionary in nature without specific product hazard details.
Plain-English summary
Accord Healthcare, Inc. is recalling Pirfenidone Tablets 801 mg following FDA identification of Current Good Manufacturing Practice (CGMP) deviations during a facility inspection. The recalled batches are P2202519 and P2202513, with an expiration date of 4/30/2024, affecting approximately 2,641 bottles.
The affected product was distributed in the United States, Puerto Rico, and Canada. The manufacturer is Intas Pharmaceuticals Limited in Ahmedabad, India, and the product is distributed by Accord Healthcare, Inc., based in Durham, North Carolina.
Patients currently taking this medication should contact their healthcare provider or pharmacist before taking any action regarding their treatment. Healthcare providers and dispensaries should address inquiries to Accord Healthcare, Inc. or the FDA's drug recall database for additional information.
The recalled product
- Product
- PIRFENIDONE (PIRFENIDONE)
- Brand
- PIRFENIDONE
- Manufacturer
- Accord Healthcare, Inc.
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batches: P2202519
- P2202513 Exp. Date 4/30/2024
UPCs (1)
- 316729468152
Distribution
Distribution scope not specified by the agency.
Related recalls
Same brand · PIRFENIDONE
- ModeratePirfenidone tablets recalled due to manufacturing process deviations
FDA (Drugs) · 2023-03-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27