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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 278,538
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.
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