drugs MODERATE Updated 2026-07-01

Direct Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30

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Recalled Product

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

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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: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.

✅ 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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View official government recall