The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) 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 manufacturing 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.

576–600 of 1441

  • HighFDA (Devices)·Z-1719-2022·2022-09-21

    Medical connector recalled due to manufacturing housing gap defect

    ICU Medical is recalling MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.

    Product
    MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1720-2022·2022-09-21

    ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap

    ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.

    Product
    8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1721-2022·2022-09-21

    Extension Set Recall Due to Connector Housing Manufacturing Defect

    ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.

    Product
    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1723-2022·2022-09-21

    ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect

    ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.

    Product
    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Drugs)·D-1535-2022·2022-09-21

    Triamcinolone Acetonide Cream Recalled Due to Manufacturing Quality Defects

    Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE CREAM)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1513-2022·2022-09-21

    Magnesium Citrate Saline Laxative Recalled for Manufacturing Deviations

    Vi-Jon, LLC voluntarily recalled Magnesium Citrate Saline Laxative due to manufacturing process deviations. Over 8 million units of the product were distributed nationwide.

    Product
    Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1654-2022·2022-09-14

    Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

    Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.

    Product
    Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Drugs)·D-1493-2022·2022-09-14

    CORRECTDOSE Children's Pain Relief and Fever Reducer Acetaminophen Recalled for Manufacturing Control Violations

    CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.

    Product
    CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1486-2022·2022-09-14

    Acetaminophen Oral Solution Recalled for Manufacturing Process Control Failures

    Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.

    Product
    Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1492-2022·2022-09-14

    CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations

    CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.

    Product
    CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1484-2022·2022-09-14

    Acetaminophen Oral Solution 160 mg Recalled for Manufacturing Control Deviations

    Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.

    Product
    Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2022·2022-09-14

    FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect

    Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.

    Product
    Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1497-2022·2022-09-07

    Triamcinolone Acetonide Cream Recalled for Manufacturing Defects

    Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2022·2022-08-31

    Dental Implant Recall: Nobel Biocare Device Burr Aspiration Risk

    Nobel Biocare is recalling 347 N1 TiUltra TCC dental implants due to a burr that may pose an aspiration risk during surgical implantation. No injuries have been reported.

    Product
    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2022·2022-08-31

    Boston Scientific Guide Catheter Distributed With Wrong Tip Curve

    Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.

    Product
    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1386-2022·2022-08-31

    Three baby ointments recalled due to improper storage conditions

    Three baby ointment products (Desitin Creamy, Baby Love, Desitin Maximum Strength) were recalled from Family Dollar Stores for being stored outside recommended temperature conditions. No illnesses or injuries have been reported.

    Product
    DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OINTMENT CREAM 4 OZ SKU 902617 DESITIN MAXIMUM STRENGTH PASTE 4 OZ SKU 903097 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1344-2022·2022-08-24

    FDA Recalls Neostigmine Methylsulfate Injectable Due to Contamination Risk

    Nephron Sterile Compounding Center is recalling one lot of Neostigmine Methylsulfate Injection due to potential cross-contamination from product carryover during manufacturing. The recall affects 13,500 vials distributed nationwide.

    Product
    PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1360-2022·2022-08-24

    Hand Sanitizer Recalled for Inadequate Microbial Control in Manufacturing

    Aire-Master of America Inc is recalling Common Sense Fragrance Free Hand Sanitizer due to a manufacturing process deviation. The product was made using deionized water from a system that lacked appropriate microbial control.

    Product
    Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1351-2022·2022-08-24

    Prescription cancer drug lot recalled for failed quality specifications

    Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.

    Product
    FULVESTRANT — FULVESTRANT (FULVESTRANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1355-2022·2022-08-24

    Avant Foaming Hand Sanitizer Recalled Due to Manufacturing Process Deviation

    Aire-Master of America Inc. is recalling Avant Foaming Hand Sanitizer because the deionized water system used in manufacturing lacked appropriate microbial control measures.

    Product
    Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1358-2022·2022-08-24

    Hand Sanitizer Recalled for Manufacturing Process Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled due to a manufacturing deficiency in the deionized water system. The product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1313-2022·2022-08-17

    Eye Drops Recalled Due to Improper Storage Violating Manufacturing Standards

    Naphcon A eye drops are being recalled nationwide because products were stored outside label specifications, violating Current Good Manufacturing Practice (CGMP) standards.

    Product
    NAPHCON A — NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1533-2022·2022-08-10

    Vicks Children's Botanicals Liquid Supplement Recalled for Improper Processing

    The Procter & Gamble Company is recalling Vicks Children's Botanicals Liquid Combo Pack because the acidified/low acid dietary supplement was manufactured without an FDA-approved process.

    Product
    Vicks Children's Botanicals Liquid Daytime/Nighttime Combo Pack 4oz plastic bottles
    Category
    Drug
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-1501-2022·2022-08-10

    Turbett Surgical Container TS1500: Unapproved Rework Processes

    Turbett Surgical, Inc. is recalling the Turbett Surgical Container TS1500 because the affected units were subject to unapproved rework processes. Seven units were distributed to healthcare facilities in Colorado, Florida, North Carolina, and Pennsylvania.

    Product
    Turbett Surgical Container, TS1500
    Category
    Medical Device
    Distribution
    Distributed nationwide