FDA Drug recall D-1426-2012
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only
- FDA Drug
- Class III
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class III recall of Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only by Fougera Pharmaceuticals, citing chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1426-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-06-07 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
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
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Identifiers
| upc | 301680215600 |
|---|---|
| code_info | Lot #: 418N, Exp 06/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Fougera Pharmaceuticals
- Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 1…
FDA Drug · Class II · 2017-03-29 · Fougera Pharmaceuticals - FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes,…
FDA Drug · Class II · 2014-11-19 · Fougera Pharmaceuticals - Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Divi…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals - Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Di…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals - Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., M…
FDA Drug · Class III · 2014-03-19 · Fougera Pharmaceuticals
All Fougera Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1426-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.