Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Levalbuterol Inhalation Solution Recalled by Cipla Limited Due to Failed Impurities/Degradation Specifications: Product is out of specification...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cipla Limited directly.
Affected Products
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Quantity: 140,625 Vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cipla Limited
Cipla Limited has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report