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
- Affected units
- 2,641
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
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 67 products in this recall →Related recalls
Same brand · PIRFENIDONE
- ModeratePirfenidone tablets recalled due to manufacturing process deviations
FDA (Drugs) · 2023-03-08
Same manufacturer · Accord Healthcare, Inc.
See all →- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19