The Recall Desk

Hazard

Documentation Error recalls

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

What the numbers show

Total
426
Critical
0
Severe
0
Most recent
2026-09-02

Of the 426 documentation error 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.

About this hazard tag

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

251–275 of 426

  • ModerateFDA (Drugs)·D-1303-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling SIU-Tri-Mix 18/1/20 Injection because documentation for environmental monitoring during production was missing.

    Product
    SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1290-2015·2015-08-12

    Apothecary Shoppe Recalls HCG Injection Due to Sterility Documentation Issues

    The Apothecary Shoppe is recalling HCG 1000 U/mL Injection vials because proper environmental monitoring documentation was missing during production.

    Product
    S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1314-2015·2015-08-12

    Apothecary Shoppe Recalls Phentolamine Vials Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Phentolamine 5 mg/mL vials in Oklahoma due to lack of documentation for environmental monitoring during production.

    Product
    SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1308-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/10 Injection vials in Oklahoma due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1294-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine Injection Due to Sterility Documentation Gaps

    The Apothecary Shoppe LLC is recalling SIU-Papaverine 30 mg/mL Injection due to a lack of documentation ensuring proper environmental monitoring during production.

    Product
    SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1292-2015·2015-08-12

    Apothecary Shoppe Recalls S-methylcobalamin Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling S-methylcobalamin 25 mg/mL injection vials because documentation for environmental monitoring during production was missing.

    Product
    S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1311-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injectable Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/20 Injectable in Oklahoma due to a lack of documentation ensuring proper environmental monitoring during production.

    Product
    SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1299-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling specific vials of Papaverine and Phentolamine Injection because documentation for environmental monitoring during production was missing.

    Product
    SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1315-2015·2015-08-12

    Apothecary Shoppe Recalls Hydroxyprogesterone Caproate Vials for Sterility Concerns

    The Apothecary Shoppe is recalling Hydroxyprogesterone Caproate 250 vials due to lack of documentation for environmental monitoring during production.

    Product
    SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1267-2015·2015-07-29

    Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg because the firm did not adequately investigate customer complaints.

    Product
    Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1247-2015·2015-07-29

    Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Zolpidem Tartrate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1262-2015·2015-07-29

    Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Zolpidem Tartrate 10 mg tablets because the company did not adequately investigate customer complaints, a violation of current Good Manufacturing Practices.

    Product
    Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0705
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1255-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1256-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 10 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 U
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1254-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1221-2015·2015-07-15

    American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations

    American Health Packaging is recalling specific lots of Azithromycin tablets because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ameri
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1220-2015·2015-07-15

    Amlodipine besylate tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling Amlodipine besylate tablets 10 mg due to current Good Manufacturing Practice (CGMP) deviations involving inadequate investigation of customer complaints.

    Product
    Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA f
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1224-2015·2015-07-15

    American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations

    American Health Packaging is recalling 3,572 cartons of Clarithromycin tablets, USP 500mg, because the firm did not adequately investigate customer complaints.

    Product
    Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ame
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1585-2015·2015-05-13

    Fujifilm Aspire HD Mammography System Recalled for User Manual Error

    Fujifilm is recalling one Aspire HD mammography system in Hawaii because the user manual lacks descriptions for handling certain recoverable errors.

    Product
    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1534-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Neg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1530-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2015·2015-04-29

    SpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document

    SpineFrontier is recalling the MISquito Pedicle Screw System Surgical Technique document because it does not adequately convey the intended use of the Rod Caliper.

    Product
    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1309-2015·2015-04-01

    Aaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions

    Aaren Scientific is recalling 28 intraocular lenses because the instructions for use do not fully comply with US requirements.

    Product
    Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataract
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0767-2015·2014-12-24

    Stryker Laparoscopic Grasper Recall Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic blunt graspers because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BLUNT GRASPER, 20CM, P/N 0250282009 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0687-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allo
    Category
    Medical Device
    Distribution
    Distributed nationwide