Monsel's — Class II drug recall D-0338-2019
Terminated recall by Gordon Laboratories, reported 2018-12-26, distributed nationwide. Superpotent Drug: contains higher levels of Iron than labeled.
| Recall number | D-0338-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gordon Laboratories, Upper Darby, PA, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2018-12-17 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,155 boxes |
| Reason classes | labeling, potency |
| NDC | 10481-0112-08 |
| Lot numbers | 04/19, 12/18, 579602, 579604, 579606, 579609 |
Product
Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Reason for recall
Superpotent Drug: contains higher levels of Iron than labeled.
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-0338-2019. 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.