The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0415-2023·Announced 2023-03-08

FDA Recalls Tadalafil Tablets Due to Manufacturing Practice Deviations

Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall results from current good manufacturing practice deviations identified during inspection. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

Accord Healthcare, Inc. is recalling Tadalafil 5 mg tablets due to current good manufacturing practice (CGMP) deviations identified during an FDA inspection. Approximately 1,113,264 bottles with multiple lot codes and expiration dates ranging from April 2023 to August 2025 are affected.

The recall was initiated following an FDA inspection that identified deviations from manufacturing standards. These deviations relate to how the product was manufactured and quality-controlled, though the specific nature of the manufacturing issues was not disclosed in the recall notice.

The affected products were distributed to pharmacies and healthcare facilities throughout the United States, including Puerto Rico, and Canada. Consumers and healthcare providers who have this medication should check their supply against the provided lot numbers and expiration dates. Patients should not discontinue their medication without consulting a healthcare provider; instead, they should contact their pharmacy to determine if they have affected product and obtain a replacement if needed.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
1,113,264

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) P2002450
  • Exp. Date 4/30/2023
  • P2003222
  • Exp. Date 5/31/2023
  • P2003223
  • P2003224
  • P2004636
  • Exp. Date 8/31/2023
  • P2005035
  • P2005038
  • P2005040
  • P2005039
  • P2005041
  • P2005606
  • Exp. Date 9/30/2023
  • P2100340
  • P2100009
  • Exp. Date 12/31/2023
  • P2100010
  • P2100044

UPCs (5)

  • 0316729372107
  • 0316729369107
  • 0316729370103
  • 316729370103
  • 316729370165

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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