CLASS II Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report
Pleo Not Tablets 5X, Oral Homeopathic Medicine recalled by Terra-Medica
Terra-Medica is recalling Pleo Not Tablets 5X, Oral Homeopathic Medicine, distributed nationwide in the US. The recall was initiated on 3 Mar 2014 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-1194-2014
- FDA event ID
- 67723
- Recalling firm
- Terra-Medica, Ferndale, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2014
- FDA classified
- 7 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 3 Mar 2014 | Recall initiated by company | |
| 7 Apr 2014 | Classified by FDA | +35 days |
| 16 Apr 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Penicillin Cross Contamination
Product as listed by the FDA
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.
Where it was distributed
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Questions about this recall
Why was it recalled?
Penicillin Cross Contamination
Which lots are affected?
Batch # 15070, EXP: June 2015; Batch # 24072, EXP: June 2017.
Where was it sold?
Products were distributed US Nationwide, to Canada, to Philippines, and 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 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 26 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
21 other products · FDA event 67723This product is part of a recall event; the main page for the event is Pleo Quent Capsules 4X, Oral Homeopathic Medicine recalled.
More recalls from Terra-Medica
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pleo Fort Suppositories 3X, 10 Suppository recalled by Terra-Medica | Terra-Medica | Other | Nationwide |
| Drug | CLASS II | Pleo Fort Capsules 4X Cartons Homeopathic Digestive Aid Medicine recalled | Terra-Medica | Other | Nationwide |
| Drug | CLASS II | Pleo-Fort Drops 5X, Homeopathic Digestive Aid Medicine recalled | Terra-Medica | Other | Nationwide |
| Drug | CLASS II | Pleo Fort Tablets 5X, Homeopathic Digestive Aid Medicine recalled | Terra-Medica | Other | Nationwide |
| Drug | CLASS II | Pleo Ex Portable Sips 5X, mL, Oral Homeopathic Medicine recalled | Terra-Medica | Other | Nationwide |