FDA (Drugs) recall action 96797

KENIL HEALTHCARE PRIVATE LIMITED recalled 20 products on 2025-05-28

The FDA (Drugs) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.

Products: 20
Announced: 2025-05-28
Critical: 0
Units: 4,095,380

Why these products were recalled

CGMP Deviations

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–20 of 20

ModerateFDA (Drugs)··2025-05-28
KOFAL Original Pain Relieving Ointment Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars distributed in Delaware and North Carolina.
Product
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recall CGMP Deviations
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Maximum Security Anticavity Gel Toothpaste recalled for CGMP deviations
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall affects toothpaste tubes distributed in Delaware and North Carolina.
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recall Due to CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Rapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.
Product
RAPIDOL (HYDROCORTISONE)
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 19,500 tubes distributed in Delaware and North Carolina.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
KOFAL Methyl Salicylate External Analgesic Ointment Recall
KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.
Product
KOFAL (METHYL SALICYLATE)
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Maximum Security Anticavity Gel Toothpaste Recalled for CGMP Deviations
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 391,680 tubes distributed in Delaware and North Carolina.
Product
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Cinnafresh Anticavity Gel Toothpaste Recalled Due to CGMP Deviations
Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.
Product
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Rapidol Triple Antibiotic Ointment Recalled for CGMP Deviations
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.
Product
RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Antifungal Drug Recalled for Manufacturing Process Deviations
Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.
Product
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Artridon Topical Analgesic Recalled for Manufacturing Process Deviations
Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.
Product
ARTRIDON (MENTHOL, METHYL SALICYLATE)
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Kingskin SacaCallos salicylic acid solution recalled for manufacturing deviations
Kingskin SacaCallos 17% salicylic acid bottles are being recalled due to manufacturing deviations. The firm initiated the voluntary recall affecting approximately 9,000 bottles distributed in Delaware and North Carolina.
Product
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Optim V Anti-Itch Cream Recalled for Current Good Manufacturing Practice Deviations
Optim V Anti-Itch Cream (Benzocaine 20% & Resorcinol 3%) is being recalled because the manufacturer did not follow current good manufacturing practice (CGMP) standards. The voluntary recall affects 6,372 tubes distributed in Delaware and North Carolina.
Product
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recall Due to Manufacturing Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (0.85 oz tubes) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Maximum Security Anticavity Gel Toothpaste recalled for CGMP deviations
Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint) distributed in Delaware and North Carolina is being recalled due to CGMP deviations identified by the manufacturer.
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to manufacturing deviations. The recall affects 150,768 tubes distributed in Delaware and North Carolina.
Product
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Maximum Security Anticavity Toothpaste Sachets Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Nature Mint Anticavity Fluoride Toothpaste recall due to manufacturing deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (6.4 oz, Lot B0067, expiring 08/31/2026) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
Category
Distribution
2 states
ModerateFDA (Drugs)··2025-05-28
Antifungal Cream Recalled for Manufacturing Deviations
Kenil Healthcare is recalling CURA HONGOS Antifungal Cream (Clotrimazole 1%, 2 oz tubes) distributed in Delaware and North Carolina due to CGMP (Current Good Manufacturing Practice) deviations detected during manufacturing.
Product
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
Category
Distribution
2 states