Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,563
Critical: 1
Severe: 288
Most recent: 2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) 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 cgmp deviation 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.

701–725 of 1563

ModerateFDA (Drugs)·D-0446-2022·2022-02-02
Promethazine HCl Topical Ointment Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Promethazine HCl Topical Ointment, 2.5% due to CGMP (Current Good Manufacturing Practice) deviations. The voluntary nationwide recall affects approximately 7,788 syringes distributed across multiple lots.
Product
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2022·2022-02-02
Phenol Topical Solution recalled for CGMP manufacturing deviations
Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
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-0444-2022·2022-02-02
Lidocaine HCl/Phenylephrine HCl Nasal Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.
Product
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0445-2022·2022-02-02
Vitamin K Oral Solution Recalled for CGMP Deviations
Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.
Product
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2022·2022-02-02
Profound-PE Dental Gel Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 175 jars of the topical oral anesthetic gel.
Product
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Category
Drug
Distribution
Distributed nationwide
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-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-0428-2022·2022-02-02
BLT Topical Cream recalled by Edge Pharma for CGMP deviations
Edge Pharma is recalling 1,173 jars of BLT Topical Cream (Benzocaine/Lidocaine/Tetracaine) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, firm-initiated Class II recall.
Product
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0389-2022·2022-01-26
Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.
Product
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0374-2022·2022-01-26
Clobetasol Propionate Foam Recalled for CGMP Deviations
Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.
Product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
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-0327-2022·2022-01-12
Pain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures
ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.
Product
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0281-2022·2021-12-22
Lidocaine Hydrochloride Topical Solution recalled for CGMP deviations
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. Affected lots were made at a facility where cracked seals in caps were found on related products.
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0242-2022·2021-11-24
Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination
Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to potential benzene contamination. The product was manufactured at a facility where other lots tested positive for benzene.
Product
TINACTIN — TINACTIN (TOLNAFTATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0254-2022·2021-11-24
Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Potential Benzene Contamination
Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF Daily Prevention deodorant powder spray due to cGMP deviations at the manufacturing facility where other lots were found contaminated with benzene.
Product
LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0087-2022·2021-11-10
Irbesartan Tablets Recalled for Impurity in Active Ingredient
Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0090-2022·2021-11-10
Lupin Pharmaceuticals Irbesartan/Hydrochlorothiazide Tablets Recalled for Impurity
Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP (300/12.5 mg) in 30-count and 90-count bottles due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient.
Product
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0088-2022·2021-11-10
Irbesartan 300 mg tablets recalled for impurity in active ingredient
Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0018-2022·2021-10-27
Cleaning Solutions Foaming Hand Sanitizer Recalled for Skin Irritation Risk
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
Product
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0017-2022·2021-10-27
Coppertone Pure & Simple Baby 50 Sunscreen Spray Recalled for cGMP Deviations
Beiersdorf Inc. is recalling 14,748 cans of Coppertone Pure & Simple baby 50 Sunscreen Spray due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide.
Product
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0016-2022·2021-10-27
Coppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for cGMP Deviations
Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 70,320 cans distributed nationwide.
Product
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0848-2021·2021-10-06
Neutrogena Beach Defense Sunscreen Spray Class II Drug Recall
Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Beach Defense water+sun protection sunscreen spray SPF 70 due to cGMP (current Good Manufacturing Practice) deviations. Approximately 411,180 cans distributed nationwide are affected.
Product
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0847-2021·2021-10-06
Neutrogena Ultra Sheer SPF 30 Body Mist Sunscreen Recall
Johnson & Johnson Consumer, Inc. is recalling approximately 196,380 cans of Neutrogena Ultra Sheer body mist sunscreen SPF 30 nationwide due to cGMP deviations. This is a voluntary recall initiated by the manufacturer.
Product
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0835-2021·2021-10-06
Neutrogena COOLDRY SPORT Sunscreen Spray Class II Recall
Johnson & Johnson Consumer, Inc. is recalling 678,384 cans of Neutrogena COOLDRY SPORT sunscreen spray nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Product
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9
Category
Drug
Distribution
Distributed nationwide