# FDA recall D-1046-2018

> **Akorn, Inc.** · Class II · drug recall initiated 2018-08-01.

## Product

Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30

## Reason for recall

Failed Impurities/Degredation Specifications:  Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.

## Distribution

Nationwide within the USA

## Key facts

- **Recall number:** D-1046-2018
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2018-08-15
- **Termination date:** 2020-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2018

## Citation

> AI Analytics. FDA recall D-1046-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1046-2018. Source: US FDA. Licensed CC0.

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