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: 2026-09-02

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.

176–200 of 1434

HighFDA (Drugs)·D-0144-2025·2024-12-25
Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect
Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.
Product
Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0139-2025·2024-12-25
Primo Topical Anesthetic Gel Recalled for Manufacturing Defect
Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.
Product
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0145-2025·2024-12-25
Topical Anesthetic Gel Recalled for Manufacturing Process Deviation
Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released to customers.
Product
SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL — SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL (BENZOCAINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0147-2025·2024-12-25
Benzocaine Topical Gel Recalled Due to Manufacturing Quality Defect
Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.
Product
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0141-2025·2024-12-25
Patterson Dental Topical Anesthetic Recalled for Manufacturing Quality Defect
Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.
Product
PATTERSON DENTAL TOPICAL ANESTHETIC — PATTERSON DENTAL TOPICAL ANESTHETIC (BENZOCAINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0148-2025·2024-12-25
FDA Recalls Benzo-Jel Topical Anesthetic Gel Due to Manufacturing Defect
Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.
Product
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0137-2025·2024-12-25
Benzocaine Topical Anesthetic Recalled for Manufacturing Equipment Defect
Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.
Product
GELATO TOPICAL ANESTHETIC — GELATO TOPICAL ANESTHETIC (BENZOCAINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0115-2025·2024-12-18
OTC Cold and Flu Medication Recalled Due to Manufacturing Process Deviations
LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.
Product
SEVERE COLD AND FLU PLUS CONGESTION — SEVERE COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0098-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0095-2025·2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0101-2025·2024-12-11
Duloxetine Capsules recalled for manufacturing impurity exceeding FDA interim limit
Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-duloxetine impurity above recommended interim limits. The affected lots were distributed in Pennsylvania, Ohio, and Puerto Rico.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0096-2025·2024-12-11
Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0077-2025·2024-12-11
FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
Product
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0582-2025·2024-12-11
Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
Product
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0090-2025·2024-12-11
ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Product
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0064-2025·2024-12-04
Absorbine Jr Pain Relieving Knee Patch recalled for manufacturing deviations
Unexo Life Sciences is recalling Absorbine Jr Pain Relieving Knee Patch nationwide due to manufacturing process deviations that do not meet FDA standards. No illnesses or injuries have been reported.
Product
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0074-2025·2024-12-04
Drug Lice Treatment Recalled Due to Manufacturing Practice Violations
Neogen Corporation has voluntarily recalled LICEOUT liquid lice treatment due to manufacturing practice violations. The recall affects 8,328 jugs distributed to institutions.
Product
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0075-2025·2024-12-04
Menthol pain relief patches recalled for manufacturing practice violations
J.R. Watkins is recalling Cooling Menthol Extra Strength Pain Relief Patches nationwide due to manufacturing practice deviations. The recall affects approximately 7,138 patches from lots JC101, JC102, and JC103.
Product
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0069-2025·2024-12-04
LILAS Feminine Pain Relief Patch recalled for manufacturing violations
Unexo Life Sciences is voluntarily recalling LILAS Feminine Pain Relief Patch nationwide due to manufacturing practice deviations affecting 363,300 patches.
Product
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0066-2025·2024-12-04
FDA Recalls Menthol Medicated Patches Due to Manufacturing Deviations
FDA recalls THERA CARE COLD HOT MEDICATED PATCH (menthol 5%) due to manufacturing practice deviations. The voluntary recall affects 279,936 patches distributed nationwide.
Product
THERA CARE COLD HOT MEDICATED PATCH — THERA CARE COLD HOT MEDICATED PATCH (MENTHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0072-2025·2024-12-04
Parche Leon pain relief patches recalled for manufacturing deviations
Unexo Life Sciences Private Limited is voluntarily recalling Parche Leon pain relief patches due to manufacturing practice deviations. No illnesses or injuries have been reported.
Product
PARCHE LEON — PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0495-2025·2024-11-27
Abbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect
Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.
Product
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0493-2025·2024-11-27
Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect
Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.
Product
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0491-2025·2024-11-27
Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
Product
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0496-2025·2024-11-27
Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy
Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.
Product
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
Category
Medical Device
Distribution
Distributed nationwide