ClomiPHENE CITRATE Tablets — Class III drug recall D-1813-2015
Terminated recall by EMD Serono, Inc., reported 2015-09-23, distributed nationwide. Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
| Recall number | D-1813-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EMD Serono, Inc., Rockland, MA, United States |
| Recall initiated | 2015-09-10 |
| Classified | 2015-09-15 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 37,078 cartons |
| Reason classes | chemical contamination, specification failure |
| NDC | 00093-0041-03 |
| Lot numbers | 02/16, 233169 |
Product
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.
Reason for recall
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
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-1813-2015. 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.