CLASS II Drug recall · Reported 5 Feb 2020 · FDA Enforcement Report
Sildenafil 200 mg Troche (Clinic) recalled by MPRX
MPRX is recalling Sildenafil 200 mg Troche (Clinic), distributed in Texas. The recall was initiated on 18 Dec 2019 and the FDA has classified it as Class II.
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-0814-2020
- FDA event ID
- 84527
- Recalling firm
- MPRX, Dallas, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2019
- FDA classified
- 29 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
Timeline
| 18 Dec 2019 | Recall initiated by company | |
| 29 Jan 2020 | Classified by FDA | +42 days |
| 5 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Sildenafil 200 mg Troche (Clinic)
Where it was distributed
TX
Questions about this recall
Why was it recalled?
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Which lots are affected?
Lot: 61392:42 Use by: 05/05/2020
Where was it sold?
TX
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 products in this recall event
17 other products · FDA event 84527This product is part of a recall event; the main page for the event is Squaric Acid 0.1% Topical Solution (Clinic) recalled by MPRX.
More recalls from MPRX
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Liothyronine (T3) 80 mcg SR cap recalled by MPRX | MPRX | Other | TX |
| Drug | CLASS II | T3/T4 SR 9 mcg recalled by MPRX | MPRX | Other | TX |
| Drug | CLASS II | Tadalafil 20 mg Troche recalled by MPRX | MPRX | Hidden Drug Ingredients | TX |
| Drug | CLASS II | DHEA/Pregnenol One 10.25 MG Cap recalled by MPRX | MPRX | Other | TX |
| Drug | CLASS II | Liothyronine (T3) 92.5 MCG recalled by MPRX | MPRX | Other | TX |