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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 2026-05-13

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

Check these codes: Lot: 241069C, Exp 05/31/2027

165,761 90-count bottles · distributed nationwide in the usa Recall D-0522-2026 on FDA.gov ↗
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