Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Albuterol Sulfate Inhalation Solution Recalled by Actavis Inc Due to Failed Impurities/Degradation Specifications: Product is out of specification...

Date: January 12, 2017
Company: Actavis Inc
Status: Terminated
Source: FDA (Drug)

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 Actavis Inc directly.

Affected Products

Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53

Quantity: 164,844 units

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.

Affected (51 states)Not affected

About Actavis Inc

Actavis Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report