The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 283 (18%) 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 cgmp deviation 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.

151–175 of 1552

  • 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-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-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-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-0133-2026·2025-11-05

    Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2026·2025-11-05

    Testosterone and triamcinolone 37.5 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 43,424 sterile Testosterone / Triamcinolone Acetonide 37.5MG/7.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0134-2026·2025-11-05

    Testosterone and triamcinolone pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 31,124 sterile Testosterone / Triamcinolone Acetonide 62.5MG/12.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
    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-0130-2026·2025-11-05

    Testosterone and triamcinolone 12.5 mg pellets recalled over metal particulate

    FarmaKeio Outsourcing is recalling 18,124 sterile Testosterone / Triamcinolone Acetonide 12.5MG/2.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2026·2025-11-05

    Prazosin 5 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 107,673 units of Prazosin Hydrochloride Capsules 5 mg because test results for N-nitroso Prazosin impurity C exceeded 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-0126-2026·2025-11-05

    Testosterone 87.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0131-2026·2025-11-05

    Combination hormone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 36,924 sterile Testosterone / Triamcinolone Acetonide 25MG/5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2026·2025-11-05

    Testosterone 200 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 14,329 sterile Testosterone Regular Release 200 mg pellets over the potential presence of metal particulate matter.

    Product
    Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2026·2025-11-05

    Testosterone 62.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 62.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0137-2026·2025-11-05

    Testosterone and triamcinolone 200 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 264,664 sterile Testosterone / Triamcinolone Acetonide 200MG/40MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2026·2025-11-05

    Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 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-0105-2026·2025-11-05

    Prazosin capsules recalled over nitrosamine impurity above the acceptable intake limit

    Teva Pharmaceuticals USA is recalling 291,512 bottles of Prazosin Hydrochloride Capsules 2 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2026·2025-11-05

    Desipramine 25 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets USP 25 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-0128-2026·2025-11-05

    Testosterone 50 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 4,829 sterile Testosterone Regular Release 50 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
    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
  • HighFDA (Drugs)·D-0104-2026·2025-11-05

    Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0123-2026·2025-11-05

    Testosterone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2026·2025-11-05

    Testosterone and triamcinolone 87.5 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 21,324 sterile Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2026·2025-11-05

    Testosterone 50 mg pellets recalled over potential presence of metal particulate

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 50 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
    Category
    Drug
    Distribution
    Distributed nationwide