EMD Serono Recalls Clomiphene Citrate Tablets Due to Chemical Contamination
EMD Serono is recalling specific lots of Clomiphene Citrate tablets because the active ingredient failed due to chemical contamination.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, aligning with the Moderate severity level for low-risk contamination or voluntary precautionary actions.
Plain-English summary
EMD Serono, Inc. is recalling 37,078 cartons of Clomiphene Citrate Tablets, USP, 50 mg. The product is a prescription-only medication manufactured in Israel by TEVA Pharmaceutical Ind. Ltd. and distributed nationwide.
The recall was initiated because the active ingredient failed due to chemical contamination. The affected product is identified by Lot # 233169 and has an expiration date of 02/16.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- 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…
- Manufacturer
- EMD Serono, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 37,078
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 233169
- Exp 02/16
Distribution
Distributed nationwide across the United States.
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