The Recall Desk
ModerateFDA (Drugs)·D-0392-2023·Announced 2023-03-08

Finasteride 5 mg Tablets Recalled Due to Manufacturing Process Deviations

Accord Healthcare is recalling Finasteride 5 mg tablets due to manufacturing process deviations discovered during FDA inspection. Over 2.7 million bottles distributed in the US, Puerto Rico, and Canada are affected.

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: FDA Class II recall due to manufacturing process deviations with no reported illnesses or injuries; precautionary in nature, fitting the category of voluntary precautionary recalls.

Plain-English summary

Accord Healthcare, Inc. is recalling Finasteride 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. The affected tablets were manufactured by Intas Pharmaceuticals Limited in India and distributed throughout the United States, Puerto Rico, and Canada.

The recall includes over 2.7 million bottles in multiple package sizes (30-count, 90-count, 100-count, and 500-count) with various lot numbers and expiration dates ranging from February 2023 through June 2025. No illnesses or injuries related to these products have been reported to date.

Patients currently taking Finasteride should consult their healthcare provider or pharmacist before making any changes to their medication regimen. For specific lot numbers, packaging details, and additional information, patients and healthcare providers should contact Accord Healthcare, Inc. or visit the FDA's drug recalls website.

The recalled product

Product
FINASTERIDE (FINASTERIDE)
Brand
FINASTERIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
2,731,365

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 (20)

  • Batches: a) P2001383
  • Exp. Date 2/28/2023
  • P2004886
  • Exp. Date 8/31/2023
  • P2100853
  • Exp. Date 11/30/2023
  • P2101652
  • Exp. Date 2/29/2024
  • P2101821
  • P2102146
  • Exp. Date 3/31/2024
  • P2107270
  • Exp. Date 10/31/2024
  • P2107939
  • P2201491
  • Exp. Date 2/28/2025
  • b) P2001377
  • P2005673
  • Exp. Date 9/30/2023
  • P2005911

UPCs (5)

  • 0316729090100
  • 316729090100
  • 316729090155
  • 316729090018
  • 316729090162

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 →

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