The Recall Desk

Hazard

Manufacturing Non Compliance recalls

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

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2024-05-29

Of the 11 manufacturing non compliance 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 manufacturing non compliance 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.

1–11 of 11

  • HighFDA (Devices)·Z-2072-2024·2024-05-29

    Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope

    Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2024·2024-05-29

    Medline Piston Syringes Recalled for Non-Compliant Manufacturing Specifications

    Jiangsu Shenli Medical is recalling 12,160 Medline piston non-sterile syringes (Model 91878) because manufacturing sizes and configurations exceed FDA 510(k) clearance scope. Distribution was nationwide via U.S. ports.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2024·2023-11-01

    Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure

    Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.

    Product
    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0062-2024·2023-11-01

    Universal Meditech diagnostic test strips recalled for unauthorized distribution

    Universal Meditech is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.

    Product
    Lem Fertility LH Ovulation Test (Strip) REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0525-2022·2022-02-16

    Zee Cold Tabs Recalled for CGMP Manufacturing Deviations

    ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0832-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson is recalling Neutrogena COOLDRY SPORT sunscreen spray SPF 30 in two sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 469,764 cans.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skill
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0860-2021·2021-08-18

    Monfefo Turmeric Shot Recalled Due to Manufacturing Non-Compliance

    Monfefo LLC is recalling Monfefo brand Turmeric Shot in 2oz glass bottles because the product was not manufactured according to specifications. Affected lots were distributed across multiple states.

    Product
    Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend; packaged in glass bottle
    Category
    Food
    Distribution
    19 states