The Recall Desk

Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,434
Critical
7
Severe
107
Most recent
2026-09-09

Of the 1,434 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 107 (7%) 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 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 1434

  • 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
  • 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-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-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
  • 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-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
  • 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
  • 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-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
  • 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-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
  • 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
  • HighFDA (Devices)·Z-1480-2022·2022-08-03

    Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect

    Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1183-2022·2022-07-13

    Boric Acid 600 mg Capsules Recalled for Insanitary Manufacturing Conditions

    The FDA has recalled Boric Acid 600 mg capsules (Lot #000-03868160, Exp: 09/14/22) manufactured by Wedgewood Village Pharmacy due to insanitary conditions and lack of processing controls observed during FDA inspection. The recalled product was distributed nationwide.

    Product
    Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1184-2022·2022-07-13

    Boric Acid Vaginal Suppositories Recalled Due to Manufacturing Control Defects

    Wedgewood Village Pharmacy is recalling Boric Acid 600 mg vaginal suppositories (Lot #000-03843532) nationwide due to insanitary manufacturing conditions and lack of processing controls detected during an FDA inspection. No illnesses have been reported.

    Product
    Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1186-2022·2022-07-13

    Estriol Vaginal Cream Recalled Due to Insanitary Manufacturing Conditions

    Wedgewood Village Pharmacy is recalling Estriol vaginal cream nationwide due to insanitary manufacturing conditions and lack of processing controls identified during an FDA inspection.

    Product
    Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1176-2022·2022-07-13

    Testosterone Cypionate Injectable Drug Recalled for Manufacturing Deviations

    Sun Pharmaceutical is recalling 27 vials of Testosterone Cypionate Injection (200 mg/mL) due to manufacturing deviations caused by abnormal machinery appearance. The recall affects multiple lot numbers distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1163-2022·2022-07-06

    Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

    PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide