# FDA recall D-0218-2026

> **Cipla USA, Inc.** · Class II · drug recall initiated 2025-10-24.

## Product

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

## Reason for recall

Failed stability specifications: Out of specification for hardness test

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0218-2026
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-24
- **Report date:** 2025-12-17

- **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-0218-2026

## Citation

> AI Analytics. FDA recall D-0218-2026. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/D-0218-2026. Source: US FDA. Licensed CC0.

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