The Recall Desk

Hazard

Physical Defect recalls

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

What the numbers show

Total
65
Critical
0
Severe
4
Most recent
2023-04-19

Of the 65 physical defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) 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 physical defect 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.

26–50 of 65

  • HighFDA (Devices)·Z-2117-2015·2015-07-29

    FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.

    Product
    NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1206-2015·2015-07-08

    Takeda Recalls Contrave Tablets Due to Broken or Split Defects

    Takeda Pharmaceuticals is recalling 3,619 bottles of Contrave extended-release tablets due to potential tablet defects, including broken tablets and equatorial splitting.

    Product
    CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2015·2015-04-22

    NobelReplace Dental Implants Recalled for Packaging Material Contamination

    Nobel Biocare is recalling 23 units of NobelReplace CC PMC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2015·2015-03-25

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects

    Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.

    Product
    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0397-2015·2015-03-11

    Qualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size

    Qualitest Pharmaceuticals is recalling 2,808 bottles of Amlodipine Besylate tablets because one lot contains oversized tablets.

    Product
    AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2015·2015-01-14

    Actavis Recalls Gabapentin Capsules Due to Physical Defects

    Actavis Elizabeth LLC is recalling specific lots of Gabapentin 400 mg capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0338-2015·2015-01-14

    Actavis Recalls Gabapentin Capsules Due to Physical Defects

    Actavis Elizabeth LLC is recalling 29,622 bottles of Gabapentin capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0299-2015·2014-12-24

    Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Capsules

    Zydus Pharmaceuticals is recalling 58,920 bottles of Benzonatate Capsules, 200 mg, because some capsules are wet or leaking.

    Product
    Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0292-2015·2014-12-17

    Pfizer Recalls Tikosyn Capsules Due to Potential Cracks or Breakage

    Pfizer is recalling Tikosyn (dofetilide) capsules because they may be cracked or broken. The recall affects 31,569 bottles shipped to 4,447 direct accounts.

    Product
    TIKOSYN — TIKOSYN (DOFETILIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0258-2015·2014-12-03

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Split Tablets

    Actavis Laboratories is recalling 5,451 bottles of Diclofenac Sodium and Misoprostol tablets because some contain split or broken tablets.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0239-2015·2014-11-12

    Physicians Total Care Recalls Loratadine Tablets Due to Chipped or Broken Pieces

    Physicians Total Care is recalling specific lots of Loratadine 24 HR-OTC 10 mg tablets because they may contain chipped or broken pieces.

    Product
    Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2015·2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0118-2015·2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2015·2014-10-15

    Zydus Recalls Atenolol Tablets Due to Superpotent Drug Complaint

    Zydus Pharmaceuticals is recalling 5,400 bottles of Atenolol 25 mg tablets nationwide after a pharmacist reported that several tablets appeared noticeably thicker.

    Product
    ATENOLOL — ATENOLOL (ATENOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1616-2014·2014-10-08

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

    Actavis is recalling 36,538 bottles of Diclofenac Sodium and Misoprostol tablets due to complaints of split or broken tablets.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1617-2014·2014-10-08

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

    Actavis is recalling 6,041 bottles of Diclofenac Sodium and Misoprostol tablets because they may be split or broken.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1558-2014·2014-09-03

    Perrigo Recalls CareOne Nicotine Lozenges for Dissolution Failures

    Perrigo Holland Inc is recalling CareOne Nicotine Polacrilex Lozenges because they failed dissolution tests and contained broken lozenges.

    Product
    CAREONE NICOTINE — CAREONE NICOTINE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-1927-2014·2014-07-02

    Siemens Healthcare Recalls ADVIA Acid/Base Reagent Kits Due to Metal Contamination

    Siemens Healthcare is recalling ADVIA Acid/Base Reagent 1 and 2 Kits because trace metal contamination caused the acid bottles to swell.

    Product
    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2014·2014-06-18

    Ivoclar Vivadent Recalls Bluephase Style Light Probes Due to Broken Glass Fibers

    Ivoclar Vivadent is recalling 241 Bluephase style light probes because a stock check revealed broken glass fibers between the connector and the fiber bundle.

    Product
    bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1759-2014·2014-06-18

    Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 84 sterile 5.5mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.

    Product
    Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1239-2014·2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count N
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1241-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette 2 mg lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-1164-2014·2014-03-26

    RX3 Pharmacy Recalls Hydroxyprogesterone Caproate Syringes Due to Crystallization

    RX South LLC is recalling 250 syringes of Hydroxyprogesterone Caproate 250mg/ml due to visible crystals formed by extreme cold during shipping.

    Product
    Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION
    Category
    Drug
    Distribution
    2 states