CLASS I Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Reumofan Plus tablets per, distriubted by Reumofan Plus USA recalled
Reumofan Plus U is recalling Reumofan Plus tablets per, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, distributed nationwide in the US. The recall was initiated on 4 Jan 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-837-2013
- FDA event ID
- 64182
- Recalling firm
- Reumofan Plus U, Springfield, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Jan 2013
- FDA classified
- 2 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 4 Jan 2013 | Recall initiated by company | |
| 2 Aug 2013 | Classified by FDA | +210 days |
| 14 Aug 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Product as listed by the FDA
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.
Where it was distributed
Nationwide through internet sales.
Stores named: Online Retailers
Questions about this recall
Is Reumofan Plus tablets per, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC recalled?
Yes. Reumofan Plus U recalled Reumofan Plus tablets per, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC on 4 Jan 2013. The recall is Class I and its status is Terminated. Recall number D-837-2013.
Why was it recalled?
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Which lots are affected?
Lot #: 99515, Exp 09/2016
Where was it sold?
Nationwide through internet sales.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Reumofan plus recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Reumofan Plus Tablets recalled by Pain Free By Nature | Pain Free By Nature | Labeling Errors | Nationwide |
| Drug | CLASS I | Reumofan Plus Tablets bottle recalled by Samantha Lynn | Samantha Lynn | Labeling Errors | Nationwide |