The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1294-2022·Announced 2022-08-03

Jubilant Cadista Irbesartan tablets recalled due to failed dissolution

Jubilant Cadista Pharmaceuticals is recalling 28,560 bottles of Irbesartan 75 mg tablets nationwide due to failed dissolution specifications that may compromise drug efficacy.

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 classified as FDA Class II with no reported hospitalizations or injuries. The failed dissolution specification constitutes a risk-of-harm to patients requiring blood pressure control, but no adverse events have been reported, making this a High-severity precautionary recall.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 28,560 bottles of Irbesartan (Irbesartan Tablets, USP, 75 mg) nationwide. The recall affects lots IB120012A, IB120013A, and IB120014A with an expiration date of August 2022. The products are being recalled because they failed to meet dissolution specifications during quality testing, which may affect how the medication is absorbed in the body.

Irbesartan is an angiotensin II receptor blocker used to treat high blood pressure. If tablets do not dissolve properly, patients may not receive the intended dose of medication, potentially compromising therapeutic effectiveness.

Patients taking Irbesartan from the affected lots should not stop taking their medication without first consulting their healthcare provider. Those affected should contact their pharmacist or physician to determine if they have affected product and discuss alternative treatment options.

The FDA is monitoring this recall. For more information, consumers can contact Jubilant Cadista Pharmaceuticals, Inc., or visit the FDA's drug recalls website.

The recalled product

Product
IRBESARTAN (IRBESARTAN)
Brand
IRBESARTAN
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
28,560

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 (3)

  • Lot #: IB120012A
  • IB120013A
  • IB120014A Exp. date 08/2022

UPCs (3)

  • 0359746447304
  • 0359746448301
  • 0359746449308

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Jubilant Cadista 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 2 products in this recall →

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