FDA Recall D-0593-2025

Cipla USA, Inc. · Warren, NJ

Class III Ongoing 294 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.

Lot / code: Lot#: 4IB0519, Exp. 04/30/2026

Quantity: 20352 packs (1x 200 MD)

Reason for recall

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

Recall record

Recall number: D-0593-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide.
Recall initiated: 2025-07-24
Classified by FDA Center: 2025-08-20
FDA published: 2025-08-27
Recalling firm: Cipla USA, Inc.
Firm location: Warren, NJ

Drug identification

Brand name(s): ALBUTEROL SULFATE
Generic name(s): ALBUTEROL SULFATE
Manufacturer(s): Cipla USA Inc.
NDC(s): 69097-142
Route(s): RESPIRATORY (INHALATION)

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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