Erythromycin Topical Solution USP — Class III drug recall D-1426-2012
Terminated recall by Fougera Pharmaceuticals, Inc., reported 2012-08-01, distributed nationwide. Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthal
| Recall number | D-1426-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals, Inc., Hicksville, NY, United States |
| Recall initiated | 2012-06-07 |
| Classified | 2012-07-25 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2015-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 444 bottles |
| Reason classes | chemical contamination |
| NDC | 00168-0215-60 |
| Lot numbers | 06/13, 418N |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1426-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.