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.

751–775 of 1434

ModerateFDA (Drugs)·D-0434-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling 63 vials of Dibutyl Squaric Acid Topical Solution (2%, 10 mL per vial) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0436-2022·2022-02-02
LT Topical Cream Recalled for Manufacturing Practice Deviations
Edge Pharma, LLC is recalling 74 jars of LT Topical Cream (Lidocaine/Tetracaine) nationwide due to deviations from Current Good Manufacturing Practice (CGMP). The firm initiated the voluntary recall on December 6, 2021.
Product
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0441-2022·2022-02-02
Profound-PE Dental Gel Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.
Product
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0440-2022·2022-02-02
Profound Dental Gel Recalled for CGMP Manufacturing Deviations
Edge Pharma, LLC is recalling 221 jars of Profound Dental Gel (Lidocaine/Prilocaine/Tetracaine 10%/10%/4%) nationwide due to Good Manufacturing Practice (CGMP) deviations identified during production.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0435-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to CGMP Deviations
Edge Pharma, LLC is recalling 20 vials of Dibutyl Squaric Acid topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The drug was distributed in multiple dose vials containing 1%, 10 mL each.
Product
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0448-2022·2022-02-02
Vancomycin HCl Oral Solution Recalled for CGMP Deviations
Edge Pharma is voluntarily recalling 6,925 syringes of Vancomycin HCl Oral Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process.
Product
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2022·2022-02-02
Tetracaine HCl Nasal Solution Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Tetracaine HCl Nasal Solution, 4%, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 114 bottles distributed nationwide.
Product
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0433-2022·2022-02-02
Drug Recall: Dexamethasone Sodium Phosphate Topical Solution
Edge Pharma, LLC is recalling Dexamethasone sodium phosphate 0.4% topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in 56 cartons.
Product
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0430-2022·2022-02-02
Cantharidin PLUS topical suspension recalled for manufacturing deviations
Edge Pharma, LLC is recalling 2,204 vials of Cantharidin PLUS, a topical gel-forming suspension used to treat skin conditions. The recall is due to manufacturing quality control deviations discovered during production.
Product
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0439-2022·2022-02-02
Drug Recall: Profound Dental Gel CGMP Deviations
Edge Pharma is voluntarily recalling 353 jars of Profound Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0391-2022·2022-01-26
Extra Strength Headache tablets recalled for CGMP manufacturing deviations
Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.
Product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0383-2022·2022-01-26
Equate Allergy Relief D Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Equate Allergy Relief D Extended-Release Tablets distributed by Walmart nationwide due to failed dissolution specifications. The recall affects 137,856 boxes across multiple lot numbers.
Product
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart In
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0488-2022·2022-01-19
Orthopaedic Stem Implants Recalled for Undersized Bore Manufacturing Defect
DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.
Product
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2022·2022-01-19
Hip stem implants recalled due to undersized bore defect
DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.
Product
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0366-2022·2022-01-19
Metformin 750 mg Extended Release Recalled for NDMA Contamination
RemedyRepack Inc. is recalling Metformin 750 mg Extended Release (NDC # 70518-2920-00) due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the acceptable daily intake limit. The product was distributed to one direct account in Pennsylvania.
Product
Metformin 750 mg Extended Release NDC # 70518-2920-00
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0453-2022·2022-01-12
Medshape DYNANAIL MINI surgical nail recalled for improper endcap length
Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.
Product
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Category
Medical Device
Distribution
9 states
ModerateFDA (Drugs)·D-0361-2022·2022-01-12
Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects
Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.
Product
PREGABALIN — PREGABALIN (PREGABALIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2022·2022-01-05
Ultimum Hemostasis Introducer devices recalled due to manufacturing error
Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.
Product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2022·2021-12-22
MENTOR Saline-Filled Breast Implants Recalled for Deflation Risk
Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.
Product
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0283-2022·2021-12-22
Methylcobalamin Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated, dba Cape Drugs, is recalling Methylcobalamin 12mg/ml injection (Lot #188008) due to lack of processing controls. The recall affects 27 vials distributed in Maryland.
Product
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0284-2022·2021-12-22
B-Complex Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated dba Cape Drugs is recalling B-Complex injection in 1 mL vials (Lot# 190036, BUD 12/27/2021) distributed in Maryland due to lack of processing controls.
Product
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0279-2022·2021-12-22
Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.
Product
LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0344-2022·2021-12-15
Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0338-2022·2021-12-15
Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error
The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.
Product
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0339-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect
Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.
Product
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Category
Medical Device
Distribution
Distributed nationwide