drugs MODERATE Updated 2026-05-13

Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-c

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Recalled Product

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.

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 241069C, Exp 05/31/2027

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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