CLASS III Drug recall · Reported 23 Sep 2015 · FDA Enforcement Report
ClomiPHENE Citrate Tablets, USP, 50 mg (2 of each) recalled
EMD Serono is recalling ClomiPHENE Citrate Tablets, USP, 50 mg (2 of each) per, distributed nationwide in the US. The recall was initiated on 10 Sep 2015 and the FDA has classified it as Class III.
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-1813-2015
- FDA event ID
- 72172
- Recalling firm
- EMD Serono, Rockland, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Sep 2015
- FDA classified
- 15 Sep 2015
- Reported
- 23 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Sep 2015 | Recall initiated by company | |
| 15 Sep 2015 | Classified by FDA | +5 days |
| 23 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Which lots are affected?
Lot #: 233169, Exp 02/16
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from EMD Serono
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cetrotide (cetrorelix acetate for Injection) 0.25 mg recalledCetrotide | EMD Serono | Foreign Material | Nationwide |
Other Clomiphene recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ClomiPHENE Citrate Tablets, USP 50 mg recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |