The Recall Desk
HighFDA (Drugs)·D-0417-2023·Announced 2023-03-08

Tadalafil Tablets Recalled Due to Manufacturing Practice Deviations

Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.

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: This is an FDA Class II recall involving manufacturing process deviations that represent a risk of harm to product quality and safety, though no illnesses or injuries have been reported. CGMP deviations in pharmaceutical manufacturing indicate potential issues with product integrity and potency.

Plain-English summary

Accord Healthcare, Inc. is recalling Tadalafil 20 mg tablets distributed under the brand name TADALAFIL in 30-count and 500-count bottles. Approximately 613,553 bottles are subject to this recall, with NDC numbers 16729-372-10 and 16729-372-16.

Multiple batch codes are involved, with expiration dates ranging from April 2023 through March 2025. The affected product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, for Accord Healthcare, Inc. in Durham, North Carolina.

The FDA inspection identified Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process. These deviations indicate that manufacturing conditions did not meet FDA's quality standards.

The affected product was distributed throughout the United States, including Puerto Rico and Canada.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
  • cgmp-deviation

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) P2002461
  • Exp. Date 4/30/2023
  • P2002457
  • P2002460
  • P2002464
  • P2002463
  • P2002462
  • P2002465
  • P2003153
  • Exp. Date 5/31/2023
  • P2003155
  • P2003156
  • P2003154
  • P2003152
  • P2003157
  • P2003158
  • P2003159
  • P2003162
  • P2003160
  • P2003778

UPCs (5)

  • 0316729372107
  • 0316729369107
  • 0316729370103
  • 316729372107
  • 316729372169

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · TADALAFIL

Same category