# FDA recall D-0019-2026

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2025-09-19.

## Product

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90),  b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

## Reason for recall

Failed Dissolution Specifications

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0019-2026
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-19
- **Report date:** 2025-10-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2026

## Citation

> AI Analytics. FDA recall D-0019-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0019-2026. Source: US FDA. Licensed CC0.

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