The Recall Desk

Hazard

Manufacturing Quality Deviation recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2024-10-09

Of the 2 manufacturing quality deviation 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 manufacturing quality 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.

1–2 of 2

  • HighFDA (Drugs)·D-0007-2025·2024-10-09

    Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations

    Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.

    Product
    Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1088-2023·2023-08-30

    Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 400 mg tablets due to manufacturing quality deviations. The affected batch was released prior to approval.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide