drugs MODERATE Updated 2026-06-17

Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 241180C, Exp. Date April 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.

Looking for a safe alternative?

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