Reumofan Plus — Class I drug recall D-837-2013
Terminated recall by Reumofan Plus USA, reported 2013-08-14, distributed nationwide. Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclof
| Recall number | D-837-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reumofan Plus USA, Springfield, PA, United States |
| Recall initiated | 2013-01-04 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2015-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 586 bottles |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 99515 |
| Expiration dates | 2016-09 |
Product
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
Reason for recall
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
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-837-2013. 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.