The Recall Desk
CriticalFDA (Drugs)·D-0938-2023·Announced 2023-07-19

Prescription albuterol inhalers recalled nationwide due to defective valve seals

Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls are classified as Critical.

Plain-English summary

Cipla USA, Inc. is recalling Albuterol Sulfate Inhalation Aerosol 90 mcg inhalers distributed nationwide. The recall affects 278,538 canisters with lot numbers IB20045, IB20055, IB20056, IB20057, IB20059, and IB20072, expiring November 30, 2023.

Some canisters have a defective container with a partially missing bottom seat (gasket), which can cause inhalers to be empty when received or to leak medication through the valve.

Patients with inhalers from the recalled lot numbers should verify their lot number and consult their healthcare provider if affected. For more information, contact Cipla USA, Inc. at 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

The recalled product

Product
ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Brand
ALBUTEROL SULFATE
Manufacturer
Cipla USA, Inc.
Category
Drug — Inhalation / Respiratory
Hazard
  • empty-inhaler
  • leakage
  • container-defect

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 (8)

  • Lot # IB20045
  • IB20055
  • IB20056
  • IB20057
  • IB20059
  • IB20072
  • Exp Nov. 30
  • 2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ALBUTEROL SULFATE

Same category