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Breckenridge Pharmaceutical, Inc.

Check your batch

Check the batch codes below. If yours matches, return it for a refund rather than take it.

Class II

  • May cause temporary or medically reversible harm. Serious consequences are unlikely.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check your batch Filed 2026-06-17

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

Check these codes: Lot: 241180C, Exp. Date April 2027.

14,729 bottles. · distributed nationwide within the united states Recall D-0582-2026 on FDA.gov ↗
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