The Recall Desk
ModerateFDA (Drugs)·D-0088-2022·Announced 2021-11-10

Irbesartan 300 mg tablets recalled for impurity in active ingredient

Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.

What this means for you

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. The source text does not report any illnesses, injuries, or hospitalizations associated with the impurity. The hazard is a manufacturing deviation with potential for harm but no confirmed clinical impact.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Irbesartan Tablets USP 300 mg due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. This impurity represents a deviation from current good manufacturing practice (CGMP) standards.

The recalled products include two package sizes: 30-count bottles (NDC 68180-412-06) and 90-count bottles (NDC 68180-412-09). Approximately 119,544 bottles in total were distributed to major distributors, who may have further distributed the product nationwide. Multiple lot numbers are affected with expiration dates ranging from August 2021 through March 2023.

Patients currently taking this medication should not stop treatment without consulting their healthcare provider. Healthcare providers and patients who have this medication should contact Lupin Pharmaceuticals or speak with their pharmacist about obtaining replacement product or alternative treatment options.

The recalled product

Product
IRBESARTAN (IRBESARTAN)
Brand
IRBESARTAN
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription / Antihypertensive
Hazard
  • impurity
  • nitrosamine
  • 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 (18)

  • a) Lot# H804310
  • exp. date 31/08/2021 H900050
  • exp. date 30/11/2021 H902262
  • exp. date 31/05/2022 b) Lot# H000845
  • exp. date 28/02/2023 H000846
  • exp. date 28/02/2023 H000965
  • exp. date 31/03/2023 H805345
  • exp. date 30/11/2021 H805346
  • exp. date 30/11/2021 H805347
  • exp. date 30/11/2021 H805724
  • exp. date 30/11/2021 H900061
  • exp. date 31/12/2021 H900062
  • exp. date 31/12/2021 H900445
  • exp. date 31/01/2022 H901489
  • exp. date 31/03/2022 H901490
  • exp. date 31/03/2022 H901491
  • exp. date 31/03/2022 H902261
  • exp. date 31/05/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · IRBESARTAN

Same category