The Recall Desk

Hazard

Formulation Defect 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
2025-01-08

Of the 5 formulation defect 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.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all formulation defect 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

  • HighFDA (Drugs)·D-0172-2025·2025-01-08

    Dapsone Topical Gel Recalled Due to Crystallization Defect

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (2760 packs) distributed nationwide due to crystallization in the formulation. The voluntary recall affects lots T400514 and T400808.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0913-2023·2023-07-19

    Sunitinib Malate Capsules Recalled Due to Excess Moisture Content

    Teva Pharmaceuticals is recalling 180 bottles of Sunitinib Malate Capsules due to moisture content exceeding approved specifications. The affected lot (100037220) expires 10/2024.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0876-2023·2023-06-21

    Prescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure

    Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules (Lot HL00721A, Exp. 12/2023) due to failed dissolution specifications. The extended-release mechanism did not function properly, which could affect medication absorption.

    Product
    EXTENDED PHENYTOIN SODIUM — EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0230-2022·2021-11-17

    Tadalafil Tablets Recalled for Incorrect Product Formulation

    Sun Pharmaceutical Industries is recalling Tadalafil 5 mg tablets (Lot # DNC1127A) because an incorrect grade of Crospovidone was used during manufacturing. The product was distributed to one distributor who may have further distributed it nationwide.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2021·2021-06-23

    Dialysate Concentrate for Hemodialysis Recalled for Out-of-Specification Formulation

    Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.

    Product
    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide