The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0390-2023·Announced 2023-03-08

Finasteride tablets recalled for manufacturing practice deviations

Accord Healthcare recalls 325,356 bottles of Finasteride 1 mg tablets due to manufacturing practice deviations identified during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.

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: This is a Class II FDA recall with no reported illnesses or injuries. The recall addresses manufacturing practice deviations discovered during inspection rather than a specific identified contamination or product defect with documented harm. Per the rubric, recalls with no reported illnesses score at most 3; the manufacturing quality control nature supports a Moderate (2) rating.

Plain-English summary

Accord Healthcare, Inc. is recalling Finasteride (finasteride) 1 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection.

The recall affects 325,356 bottles distributed across the United States, including Puerto Rico and Canada. Affected packages include 30-count and 90-count bottles with specific batch numbers and expiration dates: P2005979 (10/31/2023), P2100252 (12/31/2023), P2101710 (2/29/2024), P2100253 (12/31/2023), P2103035 (4/30/2024), and P2103036 (4/30/2024).

Consumers who have purchased affected Finasteride tablets should contact Accord Healthcare or their healthcare provider with questions about the recall.

The recalled product

Product
FINASTERIDE (FINASTERIDE)
Brand
FINASTERIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
325,356

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 (10)

  • Batches: a) P2005979
  • Exp. Date 10/31/2023
  • P2100252
  • Exp. Date 12/31/2023
  • P2101710
  • Exp. Date 2/29/2024
  • b) P2100253
  • P2103035
  • Exp. Date 4/30/2024
  • P2103036

UPCs (3)

  • 0316729089104
  • 316729089104
  • 316729089159

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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