The Recall Desk
LowFDA (Drugs)·D-0302-2015·Announced 2014-12-24

Eisai Recalls Belviq Tablets Due to Missing or Illegible Labels

Eisai Inc. is recalling 121,680 bottles of Belviq (Lorcaserin HCl) 10 mg tablets because some bottles may lack labels or have illegible lot and expiry dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III and involves a packaging/labeling defect (missing or illegible labels) without reported injuries or illnesses, fitting the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Eisai Inc. is voluntarily recalling 121,680 bottles of Belviq (Lorcaserin HCl) 10 mg tablets, 60-count bottles, distributed nationwide. The recall is due to a labeling defect where bottles may not have a product label, or may have a label with a missing or illegible lot number and/or expiry date.

The affected product is manufactured by Arena Pharmaceuticals, GmbH, and distributed by Eisai Inc. The specific lots involved are #13297008, #13307008, and #13367008, all with expiration dates in November or December 2015. The NDC number for the product is 62856-52960.

Consumers who have this product should check their bottles for missing or illegible labels. If the label is missing or the lot number and expiry date cannot be read, they should stop using the product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
Manufacturer
Eisai Inc
Affected units
121,680

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 (5)

  • Lot #13297008
  • Exp. 11/15
  • 13307008
  • 13367008
  • Exp.12/15.

Distribution

Distributed nationwide across the United States.