The Recall Desk

Hazard

N Nitroso Duloxetine recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2026-05-13

Of the 5 n nitroso duloxetine recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all n nitroso duloxetine recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • ModerateFDA (Drugs)·D-0514-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2026·2026-05-13

    Duloxetine Delayed-Release Capsules 20 mg Recalled for Impurity

    Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2025·2025-08-20

    Quallent duloxetine 60 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0552-2025·2025-08-13

    Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine

    Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide