The Recall Desk
ModerateFDA (Drugs)·D-1813-2015·Announced 2015-09-23

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.

What this means for you

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 0093-
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.

Related recalls

Same manufacturer · EMD Serono, Inc.

See all →

Same hazard · chemical contamination

See all →