The Recall Desk

Hazard

Manufacturing Deviation recalls

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

About this hazard tag

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

1–25 of 314

  • ModerateFDA (Drugs)·D-0522-2026·2026-05-13

    Duloxetine delayed-release capsules recalled for N-nitroso impurity contamination

    Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg due to the presence of N-nitroso-duloxetine impurity above FDA recommended limits. The affected product was distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.

    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2026·2026-05-06

    iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance

    Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.

    Product
    IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2026·2026-04-29

    Furosemide tablets recalled for presence of N-nitroso impurity

    Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.

    Product
    FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0473-2026·2026-04-15

    Clonidine Transdermal Patches Recalled for Manufacturing Quality Deviation

    Teva Pharmaceuticals is recalling approximately 62,136 cartons of clonidine transdermal patches (0.2 mg/day) distributed in the U.S. due to manufacturing deviations involving use of an unapproved raw material.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0474-2026·2026-04-15

    Teva Pharmaceuticals recalls Clonidine Transdermal patches for manufacturing deviation

    Teva Pharmaceuticals is recalling Clonidine Transdermal System patches (0.3 mg/day) due to use of an unapproved raw material in manufacturing. Approximately 113,943 cartons were distributed in the United States.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0472-2026·2026-04-15

    Prescription Clonidine Transdermal Patches Recalled for Unapproved Raw Material

    Teva Pharmaceuticals recalls 124,054 cartons of prescription clonidine transdermal patches due to manufacturing deviations involving an unapproved raw material.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0363-2026·2026-03-11

    Max Packaging Antibacterial Towelettes Recalled for Manufacturing Deviations

    ACME United Corporation is recalling Max Packaging Antibacterial Towelettes (NDC 59647-750-01) due to manufacturing practice deviations. Specific lot numbers are affected nationwide.

    Product
    Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0375-2026·2026-03-11

    BZK Antiseptic Towelettes Recalled for Manufacturing Quality Control Issues

    ACME UNITED CORPORATION is voluntarily recalling BZK Antiseptic Towelettes nationwide due to manufacturing quality deviations. Multiple lot numbers with various expiration dates were distributed throughout the United States.

    Product
    BZK PADS — BZK PADS (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0370-2026·2026-03-11

    Cleansing towelette product recalled for manufacturing practice deviations

    ACME United Corporation has voluntarily recalled MED NAP Cleansing Towelettes distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses or injuries have been reported.

    Product
    MED NAP CLEANSING TOWELETTE — MED NAP CLEANSING TOWELETTE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0361-2026·2026-03-11

    Drug Recall: First Aid Only BZK Antiseptic Towelettes – Manufacturing Deviations

    ACME United Corporation is voluntarily recalling First Aid Only BZK Antiseptic Towelettes nationwide due to manufacturing process deviations. The recall affects multiple lot numbers with expiration dates through December 2028.

    Product
    FIRST AID ONLY BZK ANTISEPTIC — FIRST AID ONLY BZK ANTISEPTIC (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0376-2026·2026-03-11

    Antiseptic Drug Manufacturer Recalls BZK Pads Due to Manufacturing Deviations

    ACME United Corporation is recalling BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) due to manufacturing process deviations. The voluntary recall affects lots 53518 and 53519 distributed nationwide.

    Product
    BZK PADS — BZK PADS (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2026·2026-03-11

    Medi-First Antiseptic Wipes Recalled for Manufacturing Deviations Nationwide

    Medi-First Antiseptic Wipes containing benzalkonium chloride have been recalled nationwide due to manufacturing deviations. The voluntary recall affects multiple lot numbers with expiration dates through August 2028.

    Product
    MEDI-FIRST ANTISEPTIC WIPES — MEDI-FIRST ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0358-2026·2026-03-11

    First Aid Only BZK Antiseptic Towelettes Recalled for Manufacturing Deviations

    ACME United Corporation is recalling First Aid Only BZK Antiseptic Towelettes nationwide due to deviations from Good Manufacturing Practice. Consumers should stop using affected lots.

    Product
    FIRST AID ONLY BZK ANTISEPTIC — FIRST AID ONLY BZK ANTISEPTIC (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0302-2026·2026-02-18

    Pro Numb Tattoo Numbing Spray Recalled for Manufacturing Deviations

    Pro Numb Tattoo Numbing Spray (5% Lidocaine) is being recalled nationwide due to manufacturing process violations (cGMP deviations). Affected lots are J01-J14 and J55-J69 in 1 oz and 4 oz bottles.

    Product
    PRO NUMB — PRO NUMB (TATTOO NUMBING SPRAY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0260-2026·2026-01-21

    FDA recalls Encon Aquarion Preserved Cartridges for manufacturing deviations

    Encon Safety Products is recalling its AQ 120 GFEW Aquarion Preserved Cartridges nationwide due to current Good Manufacturing Practice deviations. The voluntary recall affects 7,677 bags distributed across the United States.

    Product
    AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2026·2025-12-24

    Calf Implants Recalled for Manufacturing Deviations and Lack of FDA Approval

    DSAART LLC is recalling AART Calf Implants due to manufacturing deviations from specifications and distribution without required FDA premarket approval. No injuries reported.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0204-2026·2025-12-10

    Wound Care Hydrogel Dynagel Recalled for Manufacturing Deviations

    Blossom Pharmaceuticals is recalling Dynagel Moisturizing Wound Hydrogel due to manufacturing process deviations. The recall affects 8,184 bottles distributed nationwide in the United States.

    Product
    Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0211-2026·2025-12-10

    Clotrimazole Antifungal Cream Recalled for Manufacturing Compliance Issues

    Blossom Pharmaceuticals voluntarily recalls Globe Clotrimazole Cream 1% nationwide due to manufacturing process deviations. Affected lot A472418 has not been linked to illnesses or injuries.

    Product
    CLOTRIMAZOLE — CLOTRIMAZOLE (CLOTRIMAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0208-2026·2025-12-10

    FDA Recalls Nivagen Zinc Oxide Ointment Due to Manufacturing Deviations

    Blossom Pharmaceuticals has recalled Nivagen Zinc Oxide Ointment nationwide due to current Good Manufacturing Practice (cGMP) deviations at the manufacturing facility. The recall affects 13,536 containers.

    Product
    NIVAGEN ZINC OXIDE — NIVAGEN ZINC OXIDE (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0201-2026·2025-12-10

    Drug Product Lanashield Skin Barrier Recalled Due to Manufacturing Deviations

    Blossom Pharmaceuticals recalls 9,600 containers of Lanashield Skin Barrier nationwide due to manufacturing quality deviations. Voluntary recall; no illnesses reported.

    Product
    Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0212-2026·2025-12-10

    OTC Topical Zinc Oxide Ointment Recalled for Manufacturing Process Deviations

    Blossom Pharmaceuticals is recalling Globe Zinc Oxide 20% Ointment due to manufacturing process deviations. The voluntary recall affects 33,000 containers distributed nationwide.

    Product
    ZINC OXIDE 20% — ZINC OXIDE 20% (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0209-2026·2025-12-10

    NIVAGEN zinc oxide ointment recalled for manufacturing deviations

    Blossom Pharmaceuticals voluntarily recalled 7,920 bottles of NIVAGEN Zinc Oxide Ointment (Lot A352505) distributed nationwide due to manufacturing practice deviations. The FDA classified the recall as Class II.

    Product
    NIVAGEN ZINC OXIDE — NIVAGEN ZINC OXIDE (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0202-2026·2025-12-10

    Dynashield Skin Protectant Recalled for Manufacturing Practice Deviations

    Dynashield Skin Protectant (Zinc Oxide) is being recalled by Blossom Pharmaceuticals due to manufacturing practice deviations. The recall affects approximately 1,560 containers distributed nationwide.

    Product
    DYNASHIELD — DYNASHIELD (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0203-2026·2025-12-10

    Saline Enema Recalled Due to Manufacturing Practice Deviations

    Blossom Pharmaceuticals is recalling Saline Enema (Wecare brand) due to manufacturing deviations. The recall affects 18,912 containers distributed nationwide.

    Product
    SALINE ENEMA — SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
    Category
    Drug
    Distribution
    Distributed nationwide