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.

76–100 of 314

  • ModerateFDA (Drugs)·D-0067-2025·2024-12-04

    Menthol Patch Recall Due to Manufacturing Quality Deviations

    HealthWise Menstrual Pain Relief Patch (Menthol 10%) is recalled due to manufacturing quality deviations. The firm-initiated recall affects 10,368 patches distributed nationwide in the US.

    Product
    HEALTHWISE MENSTRUAL PAIN RELIEF PATCH — HEALTHWISE MENSTRUAL PAIN RELIEF PATCH (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0070-2025·2024-12-04

    JR Watkins Menthol Pain Relief Patches Recalled for Manufacturing Deviations

    JR Watkins Cooling Pain Relief Patches are being recalled due to manufacturing process deviations identified during production.

    Product
    JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0062-2025·2024-12-04

    Topical menthol back patch recalled for manufacturing deviations

    ABSORBINE jr. Extra Large Back Patch containing 5% menthol is being recalled nationwide due to manufacturing compliance deviations. The Class II recall affects 6,848,820 patches distributed by Absorbine Jr., LLC.

    Product
    ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0065-2025·2024-12-04

    THERACARE Lidocaine Pain Relief Patches Recalled for Manufacturing Deviations

    THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (4% lidocaine) is being recalled nationwide due to manufacturing practice deviations. Unexo Life Sciences, the manufacturer, voluntarily initiated the recall after identifying quality control issues.

    Product
    THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH — THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2025·2024-11-27

    Ramipril Capsule Medication Recalled Over Unapproved Vendor Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 357,414 bottles of Ramipril 10 mg capsules due to CGMP deviations where the active pharmaceutical ingredient was sourced from an unapproved vendor. The affected product was distributed to 30 wholesalers with potential nationwide distribution.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2025·2024-11-27

    FDA recalls Ramipril 2.5 mg capsules for manufacturing control deviations

    Lupin Pharmaceuticals is recalling Ramipril 2.5 mg capsules after sourcing the active ingredient from an unapproved vendor. Approximately 112,770 bottles were distributed to wholesalers nationwide.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2025·2024-11-27

    Prescription Drug Recall: Ramipril Capsules from Unapproved Supplier

    Lupin Pharmaceuticals is recalling certain lots of Ramipril 5 mg capsules because the active ingredient was sourced from an unapproved vendor, raising concerns about product quality and safety.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2025·2024-10-30

    Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations

    Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.

    Product
    OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0667-2024·2024-10-02

    Hand Sanitizer Manufacturer Recalls Product for Manufacturing Deviations

    EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.

    Product
    EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0621-2024·2024-08-07

    Prescription azelaic acid gel recalled for manufacturing process deviations

    Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2024·2024-07-24

    Prescription Potassium Chloride Extended-Release Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers, with no reported illnesses or injuries.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0589-2024·2024-07-17

    Suntegrity IMPECCABLE SKIN Sunscreen Foundation Recalled for Manufacturing Deviations

    Suntegrity IMPECCABLE SKIN sunscreen foundation is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 8,202 tubes distributed nationwide and internationally.

    Product
    IMPECCABLE SKIN - IVORY — IMPECCABLE SKIN - IVORY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0572-2024·2024-07-10

    Topical Pain-Relief Product Recalled Due to Manufacturing Violations

    Little Moon Essentials Crampy Belly Rub, a camphor-based topical product, is being recalled nationwide and in Canada due to manufacturing deviations. The firm-initiated recall affects 788 glass jars.

    Product
    Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2024·2024-05-29

    60 mL Luer Lock Syringes Recalled for Manufacturing Outside FDA Clearance

    Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.

    Product
    Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0482-2024·2024-05-15

    Duloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits

    Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0475-2024·2024-05-01

    Minolira extended-release tablets recalled due to discontinued quality assurance program

    EPI Health is recalling 5,664 bottles of minolira tablets because the manufacturer discontinued its quality assurance program. Affected lots include T2201700 and T2201701, distributed nationwide.

    Product
    minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0461-2024·2024-05-01

    Eyewash Solution Recalled for Manufacturing Compliance Deviations

    Honeywell Inc. is recalling FENDALL 2000 PURE FLOW eyewash solution due to Current Good Manufacturing Practice deviations. The recall affects 10,605 cartridges distributed nationwide in the USA and Canada with expiration dates through June 2025.

    Product
    FENDALL 2000 PURE FLOW — FENDALL 2000 PURE FLOW (PURIFIED WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0427-2024·2024-04-03

    FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations

    The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.

    Product
    VCF CONTRACEPTIVE — VCF CONTRACEPTIVE (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0371-2024·2024-03-20

    FDA Recalls Rocuronium Bromide Injections Due to Improper Storage

    McKesson Medical-Surgical is recalling Rocuronium Bromide Injection vials due to storage outside label specifications. Seventy vials were distributed to three healthcare accounts in New Mexico, Arizona, and Utah.

    Product
    ROCURONIUM BROMIDE — ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0356-2024·2024-03-06

    FDA Recalls PROBLEND Hand Sanitizer for Manufacturing Deviations

    Seatex LLC is recalling 1,450 cases of PROBLEND Antibacterial Foaming Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations discovered at its manufacturing facility. The recall affects product distributed nationwide in the United States and Puerto Rico.

    Product
    PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0289-2024·2024-02-14

    FDA Recalls Omeza Skin Protectant Gel Due to Manufacturing Deviations

    OMEZA LLC is recalling Omeza Skin Protectant Gel due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 1,210 vials distributed nationwide.

    Product
    Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0288-2024·2024-02-14

    Omeza Lidocaine Lavage pain relief oil recalled for manufacturing practice violations

    OMEZA LLC has recalled Omeza Lidocaine Lavage pain relief oil (4,390 vials) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on January 19, 2024.

    Product
    Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2024·2024-02-07

    OralProCare Medicated Lip Treatment Recalled for Manufacturing Specification Deviations

    Den-Mat Holdings recalls OralProCare medicated lip treatment due to manufacturing quality control deviations that may affect product conformance to labeled specifications. No illnesses reported.

    Product
    OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0239-2024·2024-01-24

    Old Spice Anti-Perspirant Spray Recalled Due to Facility Benzene Contamination

    Old Spice SWEAT DEFENSE Dry Spray anti-perspirant is being recalled due to manufacturing facility issues where other product lots were found contaminated with benzene. No illnesses have been reported.

    Product
    Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical Spray Can, Net WT 3.8 oz (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC 69423-386-10, UPC 0 37000 73034 7 OR UPC 0 12044 04475 9 (12 Pack, ol
    Category
    Drug
    Distribution
    Distributed nationwide