EMD Serono Recalls Clomiphene Citrate Tablets Due to Contamination
EMD Serono recalls 37,078 cartons of Clomiphene Citrate Tablets (50 mg) due to chemical contamination impurity. Check your lot number.
Use caution until it’s fixed
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Contact the company
What happened, in plain English
EMD Serono, Inc. is recalling Clomiphene Citrate Tablets, USP, 50 mg because the active ingredient failed due to chemical contamination. The recall affects 37,078 cartons distributed nationwide. The record does not specify the specific health risks associated with this impurity. Read more at govinfonow.com/recall/43737-emd-serono-inc-recalls-clomiphene-citrate-tablets-usp-50-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/43737-emd-serono-inc-recalls-clomiphene-citrate-tablets-usp-50-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1813-2015
Cite this page
“EMD Serono Recalls Clomiphene Citrate Tablets Due to Contamination.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43737-emd-serono-inc-recalls-clomiphene-citrate-tablets-usp-50-mg. Based on FDA recall #D-1813-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1813-2015%22&limit=1).
Why it’s dangerous
The tablets contain an impurity failure due to chemical contamination of the active ingredient. The specific health consequences of this contamination are not described in the provided record.
Who’s affected
Individuals who have been prescribed Clomiphene Citrate Tablets, USP, 50 mg from EMD Serono or TEVA Pharmaceuticals USA. The record does not specify which patient groups are most at risk.
How to tell if you have this one
Look for Clomiphene Citrate Tablets, USP, 50 mg in a 10-count carton containing 2 foil-sealed plastic trays of 5 tablets each. Check for NDC 0093-0041-03, UPC 3 0093-0041-03 7, Lot # 233169, and an expiration date of 02/16.
- Brand
EMD Serono- Product
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only- Category
Drug
What to do — step by step
Check Your Medication
Verify if your medication matches the recalled NDC, UPC, lot number, and expiration date listed in the record.
Contact Your Provider
Speak with your healthcare provider or pharmacist to determine the appropriate next steps for your prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1813-2015 (September 10, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1813-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.