The Recall Desk

Hazard

Manufacturing Violation recalls

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

What the numbers show

Total
16
Critical
0
Severe
0
Most recent
2024-10-30

Of the 16 manufacturing violation 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 violation 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.

1–16 of 16

  • HighFDA (Drugs)·D-0020-2025·2024-10-30

    FDA Recalls NORepinephrine Injection Due to Manufacturing Violations

    Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2022·2022-02-09

    Drug Recall: Back Pain-Off Tablets Over cGMP Violations

    Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.

    Product
    Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1506-2019·2019-07-31

    Pharma-Natural Recalls NEOGEN-D Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 2,052 bottles of NEOGEN-D cough syrup because the product was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

    Product
    NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1497-2019·2019-07-31

    Pharma-Natural Recalls GENCONTUSS Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 3,000 bottles of GENCONTUSS cough syrup because it was manufactured with current good manufacturing practice violations.

    Product
    GENCONTUSS — GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1500-2019·2019-07-31

    FDA Recalls Dermanak Skin Cream Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling Dermanak Skin Fade Cream because it was manufactured with current good manufacturing practice violations.

    Product
    Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1821-2017·2017-04-12

    Regeneca Recalls RegeneArouse Supplements for Manufacturing Violations

    VivaCeuticals is recalling all lots of RegeneArouse herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice regulations.

    Product
    RegeneArouse
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0089-2017·2016-10-26

    Triceutical Recalls Premium Protein III Supplements for Manufacturing Violations

    Triceutical Inc. is recalling Premium Protein III Nutritional Supplements because they were not manufactured according to good manufacturing practices.

    Product
    Premium Protein III Nutritional Supplement, NET WT 16 OZ. (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219. Made in USA
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0106-2017·2016-10-26

    Triceutical Inc. Recalls Eagle Lecithin Soft Gels for Manufacturing Violations

    Triceutical Inc. is recalling Eagle Lecithin soft gels because the company failed to follow good manufacturing practices. The recall covers 1,008 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Eagle Lecithin soft gels
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0094-2017·2016-10-26

    Triceutical Recalls Joint Optima Dietary Supplements for Manufacturing Violations

    Triceutical Inc. is recalling Joint Optima dietary supplements because they were not produced under good manufacturing practices. The recall covers 1,500 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Joint Optima Rebuilds, Lubricates and Soothes Joints, Triple Strength, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305. Made in USA.
    Category
    Food
    Distribution
    3 states