The Recall Desk
ModerateFDA (Drugs)·D-1183-2014·Announced 2014-04-09

Teva Recalls Duloxetine Capsules Due to Reported Capsule Breakage

Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

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 II and is a voluntary precautionary recall based on a complaint trend regarding capsule breakage, with no reported injuries or illnesses.

Plain-English summary

Teva Pharmaceuticals USA is voluntarily recalling certain lots of Duloxetine Delayed-Release Capsules USP in 20 mg, 30 mg, and 60 mg strengths. The recall is being conducted due to a customer complaint trend regarding capsule breakage.

The affected product is Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, manufactured in Israel by Teva Pharmaceutical IND, LTD and manufactured for Teva Pharmaceuticals USA. The recall involves 598,033 bottles distributed nationwide, as well as in Guam, Puerto Rico, American Samoa, and the Virgin Islands. Affected lot numbers include 49D001 through 49D007 with expiration dates ranging from April 2015 to October 2015.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for a refund or replacement.

The recalled product

Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
598,033

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 (12)

  • Lot #: 49D001
  • Exp. 4/2015
  • 49D002
  • Exp. 6/2015
  • 49D003
  • Exp. 7/2015
  • 49D004
  • 49D005
  • 49D006
  • Exp. 9/2015
  • 49D007
  • Exp. 10/2015

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

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Same hazard · capsule breakage

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