# FDA recall D-0938-2023

> **Cipla USA, Inc.** · Class I · drug recall initiated 2023-06-27.

## Product

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

## Reason for recall

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0938-2023
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-06-27
- **Report date:** 2023-07-19
- **Termination date:** 2025-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0938-2023

## Citation

> AI Analytics. FDA recall D-0938-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0938-2023. Source: US FDA. Licensed CC0.

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