The Recall Desk
HighFDA (Drugs)·D-0416-2023·Announced 2023-03-08

Tadalafil tablets recalled for manufacturing quality control deviations

Accord Healthcare is recalling Tadalafil 10 mg tablets in the United States, Puerto Rico, and Canada due to manufacturing quality control deviations discovered during an FDA inspection.

What this means for you

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: FDA Class II recall based on manufacturing quality control deviations discovered during inspection. No adverse events have been reported, but CGMP deviations represent potential risk to product integrity in a prescription medication.

Plain-English summary

Accord Healthcare, Inc., is recalling Tadalafil tablets, 10 mg strength, in both 30-count and 500-count bottles. The recall affects approximately 176,323 bottles distributed throughout the United States, Puerto Rico, and Canada.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. This is classified as a Class II recall.

Consumers should not discard their medication without consulting their healthcare provider. Affected lot numbers and expiration dates are available in the full FDA recall notice. Consumers with questions should contact their healthcare provider or pharmacist for guidance on obtaining replacement medication.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Oral Tablet
Hazard
Affected units
176,323

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) P2002525
  • Exp. Date 4/30/2023
  • P2004442
  • Exp. Date 7/31/2023
  • P2005014
  • Exp. Date 8/31/2023
  • P2005015
  • P2005016
  • P2005825
  • Exp. Date 10/31/2023
  • P2005824
  • P2005826
  • P2100368
  • Exp. Date 12/31/2023
  • P2100444
  • P2101262
  • Exp. Date 2/29/2024
  • P2101263
  • P2200813
  • Exp. Date 1/31/2025

UPCs (5)

  • 0316729372107
  • 0316729369107
  • 0316729370103
  • 316729371100
  • 316729371162

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 →

Related recalls

Same brand · TADALAFIL

Same manufacturer · Accord Healthcare, Inc.

See all →

Same hazard · manufacturing deviation

See all →