The Recall Desk

Hazard

Impurity recalls

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

What the numbers show

Total
458
Critical
0
Severe
120
Most recent
2026-09-02

Of the 458 impurity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 120 (26%) 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 impurity 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.

1–25 of 458

  • ModerateFDA (Drugs)·D-0831-2026·2026-09-02

    Hikma Recalls Ramipril Capsules Due to Process Impurity

    Hikma Pharmaceuticals is recalling specific lots of Ramipril 10 mg capsules because they failed impurity specifications for dicyclohexylurea.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0663-2026·2026-07-15

    Medline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels

    Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.

    Product
    MEDLINE — MEDLINE (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0676-2026·2026-07-08

    Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    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
  • ModerateFDA (Drugs)·D-0301-2026·2026-02-11

    Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity

    Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2026·2026-01-21

    Fluocinolone topical solution recalled after failing an impurity specification

    Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0240-2026·2025-12-24

    Ciclopirox shampoo recalled after failing impurity specifications at eighteen months

    Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.

    Product
    Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0220-2026·2025-12-17

    Ganirelix acetate injection recalled after failing an impurity specification

    Lupin Pharmaceuticals is recalling 32,736 units of Ganirelix Acetate Injection after out of specification results for the ganirelix acetate acrylic acid adduct impurity.

    Product
    GANIRELIX ACETATE — GANIRELIX ACETATE (GANIRELIX ACETATE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0159-2026·2025-11-26

    Bromocriptine capsules recalled after an out of specification impurity result

    Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.

    Product
    BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2026·2025-11-12

    Clomipramine 25 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 25 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2026·2025-11-12

    Clomipramine 50 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 50 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2026·2025-11-12

    Clomipramine 75 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 75 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2026·2025-11-05

    Desipramine 75 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 2,418 bottles of Desipramine Hydrochloride Tablets USP 75 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2026·2025-11-05

    Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2026·2025-11-05

    Desipramine 50 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,880 bottles of Desipramine Hydrochloride Tablets USP 50 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0101-2026·2025-11-05

    Unit dose prazosin 1 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,970 unit dose cartons of Prazosin Hydrochloride Capsules 1 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0107-2026·2025-11-05

    Desipramine tablets recalled over nitrosamine impurity above acceptable daily intake

    Heritage Pharmaceuticals is recalling 6,979 bottles of Desipramine Hydrochloride Tablets USP 10 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2026·2025-11-05

    Unit dose prazosin 2 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,818 unit dose cartons of Prazosin Hydrochloride Capsules 2 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0112-2026·2025-11-05

    Desipramine 150 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

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