# FDA recall D-0316-2021

> **Zydus Pharmaceuticals (USA) Inc** · Class I · drug recall initiated 2021-02-18.

## Product

Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

## Reason for recall

Crystallization: customer complaints for crystallization in finished product.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0316-2021
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-18
- **Report date:** 2021-04-07
- **Termination date:** 2022-11-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0316-2021

## Citation

> AI Analytics. FDA recall D-0316-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0316-2021. Source: US FDA. Licensed CC0.

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