The Recall Desk

Hazard

Container Defect recalls

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

What the numbers show

Total
31
Critical
1
Severe
8
Most recent
2024-08-21

Of the 31 container defect recalls we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (26%) 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 container 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.

1–25 of 31

  • HighFDA (Drugs)·D-0632-2024·2024-08-21

    Ophthalmic solution recalled for defective container with lodged spike

    FDC Limited recalls Timolol Maleate eye drops (362,544 bottles) nationwide due to a manufacturing defect: a yellow spike from the cap lodged in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0628-2024·2024-08-14

    PEG-3350 Oral Solution Recalled for Defective Non-Sealed Pouches

    A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.

    Product
    PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID — PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0550-2024·2024-06-19

    Asmanex (Mometasone Furoate) Recalled Due to Defective Container

    Organon LLC has voluntarily recalled 2,886 units of Asmanex inhalation powder nationwide due to defective containers.

    Product
    ASMANEX — ASMANEX (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0488-2024·2024-05-15

    Timolol Maleate ophthalmic solution recalled for defective container cap nozzle

    FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0370-2024·2024-03-20

    Potassium Chloride Injection Recalled Due to Pinhole Container Defects

    B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled for defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0938-2023·2023-07-19

    Prescription albuterol inhalers recalled nationwide due to defective valve seals

    Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0079-2023·2022-12-21

    FDA Recalls Sodium Bicarbonate Injection for Defective Vials

    Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2023·2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials and Glass Breakage

    Nationwide recall of 8.4% sodium bicarbonate injection vials due to container defects causing vial breakage and glass fragments when pressurized during preparation.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2023·2022-11-02

    Sodium Bicarbonate Injection Recalled for Defective Vials with Glass Breakage Risk

    Exela Pharma Sciences is recalling 2,123,040 vials of Sodium Bicarbonate 8.4% Injection due to container defects causing vial breakage and glass release when pressurized during product preparation.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1328-2022·2022-08-17

    Difluprednate eye drops recalled for defective container closure affecting sterility

    Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.

    Product
    DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1283-2022·2022-07-27

    FDA Recalls Cipla Difluprednate Eye Drops for Defective Container Caps

    Cipla is recalling 8,136 bottles of Difluprednate ophthalmic emulsion nationwide due to defective container caps that can break and expose the medication tip, compromising sterility.

    Product
    DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1173-2022·2022-07-13

    Mometasone Furoate Topical Solution Recalled Due to Defective Containers

    Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.

    Product
    MOMETASONE FUROATE — MOMETASONE FUROATE (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1172-2022·2022-07-06

    Fluticasone Propionate Nasal Spray Recalled Due to Defective Container

    Akorn, Inc. is recalling 44,400 bottles of Fluticasone Propionate Nasal Spray nationwide due to a defective container that prevents proper dispensing. Patients should contact their healthcare provider or pharmacist.

    Product
    Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0278-2022·2021-12-22

    Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

    Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0335-2021·2021-04-28

    Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns

    Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.

    Product
    Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1308-2020·2020-06-24

    Hikma Recalls Irinotecan Hydrochloride Injection Due to Container Defect

    Hikma Pharmaceuticals is recalling 82,426 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1309-2020·2020-06-24

    Hikma Recalls Irinotecan Hydrochloride Vials Due to Container Defect

    Hikma Pharmaceuticals is recalling 17,998 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0245-2018·2018-02-07

    Neutrogena Holiday Trays Recalled for Container Leakage

    Johnson & Johnson is recalling Neutrogena Elevated 4-Holiday Trays due to defective containers that leak propellant and product.

    Product
    Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0213-2018·2018-01-17

    Dr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects

    Dr. Reddy's is recalling 1,051 vials of Docetaxel Injection USP due to defects in the vial seals that may allow the stopper to detach.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0283-2015·2014-12-03

    Hospira Recalls Lactated Ringer's Injection Due to Sterility Concerns

    Hospira is recalling 6,193,416 bags of Lactated Ringer's Injection because potential punctures may compromise sterility and cause leaks.

    Product
    Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0281-2015·2014-12-03

    Hospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags

    Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
    Category
    Drug
    Distribution
    Distributed nationwide