The Recall Desk
ModerateFDA (Drugs)·D-1184-2014·Announced 2014-04-09

Teva Recalls Duloxetine Capsules Due to Reported 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 physical integrity (breakage) rather than a confirmed high-risk contamination or reported injury.

Plain-English summary

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

The affected product is Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle. The specific NDC is 0093-7544-56. The product was manufactured in Israel by Teva Pharmaceutical IND, LTD, Jerusalem, Israel, and manufactured for Teva Pharmaceuticals USA, Sellersville, PA, 18960.

The recall covers 324,648 bottles distributed nationwide, as well as in Guam, Puerto Rico, American Samoa, and the Virgin Islands. Affected lot numbers include 50D003, 50D004, 50D005, 50D006, 50D010, 50D028, 50D029, 50D031, 50D032, and 50D033, with expiration dates ranging from 2/2015 to 11/2015. Consumers should check their medication for these specific lot numbers and expiration dates.

The recalled product

Product
Duloxetine Delayed-Release Capsules, USP, 60 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 0093-7544-56
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
324,648

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 (17)

  • Lot #: 50D003
  • Exp. 2/2015
  • 50D004
  • 50D005
  • Exp. 3/2015
  • 50D006
  • Exp. 5/2015
  • 50D010
  • Exp. 6/2015
  • 50D028
  • Exp. 9/2015
  • 50D029
  • 50D031
  • Exp. 10/2015
  • 50D032
  • 50D033
  • Exp. 11/2015

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 →

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