The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1293-2022·Announced 2022-08-03

Irbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution

Jubilant Cadista is recalling 9,600 bottles of Irbesartan Tablets (150mg) nationwide due to failed dissolution specifications. Affected lot IB220023A expires 08/2022.

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: FDA Class II recall without reported illnesses or injuries. Dissolution failure in a blood pressure medication creates risk of inadequate treatment, meeting the Score 3 criterion for risk-of-harm products where no injury has been reported.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Irbesartan Tablets, USP, 150mg. A total of 9,600 bottles of the product were distributed nationwide in the United States. The recalled medication is Lot IB220023A with expiration date 08/2022.

The recall was initiated due to failed dissolution specifications. Dissolution testing verifies that tablets break down and release their active ingredient properly. Failure to meet these specifications means the tablets may not dissolve as intended.

Patients who are taking Irbesartan from the affected lot should not stop taking their medication without medical guidance. Instead, they should contact their pharmacist or healthcare provider to discuss whether their supply is affected and what steps to take next. Patients with the affected lot number should return the medication to their pharmacy for replacement or refund.

The recalled product

Product
IRBESARTAN (IRBESARTAN)
Brand
IRBESARTAN
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Blood Pressure / Antihypertensive
Hazard
Affected units
9,600

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 (2)

  • Lot #: IB220023A
  • 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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