# FDA recall D-1426-2012

> **Fougera Pharmaceuticals, Inc.** · Class III · drug recall initiated 2012-06-07.

## Product

Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.

## Reason for recall

Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1426-2012
- **Recalling firm:** Fougera Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-07
- **Report date:** 2012-08-01
- **Termination date:** 2015-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hicksville, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1426-2012

## Citation

> AI Analytics. FDA recall D-1426-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1426-2012. Source: US FDA. Licensed CC0.

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