The Recall Desk

Hazard

Quality Assurance Failure recalls

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

What the numbers show

Total
8
Critical
0
Severe
3
Most recent
2023-05-24

Of the 8 quality assurance failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (38%) 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 quality assurance failure 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.

1–8 of 8

  • ModerateFDA (Drugs)·D-0578-2023·2023-05-24

    Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation

    RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.

    Product
    Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0827-2022·2022-05-04

    Sincalide Injectable Vials Recalled for Manufacturing Monitoring Failures

    Olympia Compounding Pharmacy is recalling 1,770 vials of Sincalide due to CGMP deviations in environmental and personnel monitoring. The manufacturer failed to properly investigate monitoring excursions prior to October 2021.

    Product
    Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical pract
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0658-2017·2017-04-19

    FDA Recalls Testosterone Micronized Bulk Due to cGMP Deviations

    Qinhuangdao Zizhu Pharmaceutical is recalling Testosterone Micronized Bulk due to cGMP deviations and lack of quality assurance. The product was distributed to six states.

    Product
    Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0657-2017·2017-04-19

    FDA Recalls Estrone Micronized Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0659-2017·2017-04-19

    FDA Recalls Ethinyl Estradiol Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling bulk Ethinyl Estradiol Micronized manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0660-2017·2017-04-19

    FDA Recalls Levonorgestrel Bulk Drug Due to cGMP Deviations

    The FDA is recalling bulk levonorgestrel manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0656-2017·2017-04-19

    FDA Recalls Estriol Micronized Bulk Drug Due to Quality Assurance Failures

    Qinhuangdao Zizhu Pharmaceutical is recalling bulk Estriol Micronized, USP, due to cGMP deviations and lack of quality assurance. The product is distributed to pharmacies in six states for prescription compounding.

    Product
    Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
    Category
    Drug
    Distribution
    6 states