Agency classClass IIOur severity:Moderate FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: manufacturing-deviation
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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