The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0414-2023·Announced 2023-03-08

Tadalafil tablets recalled due to manufacturing process deviations

Accord Healthcare is recalling Tadalafil 2.5 mg tablets following discovery of manufacturing deviations during an FDA inspection. Approximately 36,773 bottles 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 an FDA Class II recall involving manufacturing process deviations with no reported illnesses or injuries. Per the severity rubric, Class II recalls without hospitalization reports and with theoretical hazards score 2 (Moderate).

Plain-English summary

Accord Healthcare, Inc. is recalling Tadalafil Tablets, USP, 2.5 mg due to manufacturing deviations discovered during an FDA inspection. The affected medication is supplied in 30-count and 500-count bottles with varying batch codes. Approximately 36,773 bottles have been distributed across the United States, including Puerto Rico, and Canada.

The recall was initiated following identification of Current Good Manufacturing Practice (CGMP) deviations. The specific nature of these deviations is not detailed in the recall notice.

Consumers with this medication should contact their healthcare provider or pharmacist for guidance. For specific product information including affected batch numbers and NDC codes, consumers may contact the FDA or Accord Healthcare.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Oral tablet
Hazard
Affected units
36,773

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 (16)

  • Batches: a) P2002522
  • Exp. Date 4/30/2023
  • P2005817
  • P2005816
  • Exp. Date 10/31/2023
  • P2203687
  • Exp. Date 6/30/2025
  • b) P2002521
  • P2005818
  • P2100075
  • Exp. Date 12/31/2023
  • P2100996
  • P2100997
  • P2100998
  • P2100999
  • Exp. Date 1/31/2024

UPCs (5)

  • 0316729372107
  • 0316729369107
  • 0316729370103
  • 316729369107
  • 316729369169

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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