# FDA recall D-1842-2019

> **Aurobindo Pharma USA Inc.** · Class III · drug recall initiated 2019-07-29.

## Product

Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810  Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810  NDC 65862-053-99

## Reason for recall

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

## Distribution

Product was distributed nationwide by three major distributors who may have further distributed the product.

## Key facts

- **Recall number:** D-1842-2019
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-29
- **Report date:** 2019-09-04
- **Termination date:** 2021-10-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1842-2019

## Citation

> AI Analytics. FDA recall D-1842-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1842-2019. Source: US FDA. Licensed CC0.

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