The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0086-2022·Announced 2021-11-10

Lupin Irbesartan Tablets Recalled for Impurity Contamination

Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.

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: The source identifies this as an FDA Class II recall involving detection of a potentially harmful impurity (N-nitrosoirbesartan) in a prescription drug. The source text does not report any illnesses or injuries; the hazard is based on the presence of the impurity itself. Per the rubric, Class II recalls with no reported hospitalization cases but involving manufacturing deviations that could pose health risk score at 3 (High).

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Irbesartan Tablets USP, 75 mg, in two package sizes: 30-count bottles (NDC 68180-410-06) and 90-count bottles (NDC 68180-410-09). The recall was initiated due to the detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which represents a deviation from current good manufacturing practices (CGMP).

A total of 51,144 bottles have been distributed to major distributors who may have distributed the product further nationwide. Multiple lot numbers are affected across both package sizes, with expiration dates ranging from August 2021 to March 2023.

Patients currently taking this medication should contact their healthcare provider or pharmacist before stopping the medication. Healthcare providers and pharmacists should quarantine and return affected inventory to Lupin Pharmaceuticals Inc. or the appropriate wholesale distributor.

The recalled product

Product
IRBESARTAN (IRBESARTAN)
Brand
IRBESARTAN
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription / Cardiovascular
Hazard
Affected units
51,144

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)

  • a) Lot# H000843
  • exp. date 28/02/2023 H805727
  • exp. date 30/11/2021 H901579
  • exp. date 31/03/2022 b) Lot# H000844
  • exp. date 28/02/2023 H000964
  • exp. date 31/03/2023 H804311
  • exp. date 31/08/2021 H805267
  • exp. date 30/11/2021 H805268
  • exp. date 30/11/2021 H805269
  • exp. date 30/11/2021 H805725
  • exp. date 30/11/2021 H805726
  • exp. date 30/11/2021 H901497
  • exp. date 31/01/2022 H901577
  • exp. date 31/03/2022 H901578
  • exp. date 31/03/2022 H902258
  • exp. date 31/05/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Lupin Pharmaceuticals 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 5 products in this recall →

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