# FDA recall D-0005-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2022-06-21.

## Product

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.

## Reason for recall

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0005-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-21
- **Report date:** 2022-10-05
- **Termination date:** 2023-08-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2023

## Citation

> AI Analytics. FDA recall D-0005-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0005-2023. Source: US FDA. Licensed CC0.

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