Multi-event April 2025 FDA Recall Artridon by Kenil Healthcare Private Limited

This Multi-event Class II drug recall was voluntarily initiated by Kenil Healthcare Private Limited on April 24, 2025 for the product Artridon. The FDA reported the reason for recall as cgmp deviations. The product was distributed in DE and NC and the recall is currently terminated.

Reported Recall Events

D-0428-2025 TERMINATED D-0423-2025 TERMINATED D-0439-2025 TERMINATED D-0427-2025 TERMINATED D-0434-2025 TERMINATED D-0433-2025 TERMINATED D-0438-2025 TERMINATED D-0425-2025 TERMINATED D-0437-2025 TERMINATED D-0421-2025 TERMINATED D-0432-2025 TERMINATED D-0422-2025 TERMINATED D-0435-2025 TERMINATED D-0436-2025 TERMINATED D-0440-2025 TERMINATED D-0429-2025 TERMINATED D-0430-2025 TERMINATED D-0431-2025 TERMINATED D-0424-2025 TERMINATED D-0426-2025 TERMINATED

Recall Number: D-0428-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
10,000 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the product.
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.

Batch or Lot Expiration Information

Lot# Lot SP26A, Exp: 09/30/2026

Affected Packages Involved in this Recall

55758-420-02 Rapidol
55758-420-03 Rapidol

Recall Number: D-0423-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
10,788 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot SP23A, Exp Date: 03/31/2026

Recall Number: D-0439-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
150,768 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0004, Exp Date: 05/31/2026; B0060, Exp Date: 07/31/2026; Lot B0067, B0071, B0072, Exp Date: 08/31/2026; Lot B0107, B0108, Exp Date: 09/30/2026

Recall Number: D-0427-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
6,372 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot SP24A, Exp: 09/30/2026

Recall Number: D-0434-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
216,720 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0013, Exp Date: 05/31/2026; Lot B0018, Exp Date: 06/30/2026; Lot B0053, B0054, Exp Date: 07/31/2026; Lot B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101, Exp Date: 09/30/2026

Recall Number: D-0433-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
1,559,000 Sachets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0010, B0017, Exp Date: 05/31/2026; Lot B0028, B0029, B0030, Exp Date: 06/30/2026; Lot B0052, Exp Date: 07/31/2026; Lot B0091, Exp Date: 09/30/2026

Recall Number: D-0438-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
616,160 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0014, B0015, B0022, B0023, Exp Date: 05/31/2026; Lot B0024, B0025, B0026, B0027, B0033, B0034, B0035, B0039, B0040, B0041, B0045, Exp Date: 06/30/2026; Lot B0046, Exp Date: 07/31/2026

Recall Number: D-0425-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
16,248 Jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lost SP21A, Exp Date: 03/31/2026

Recall Number: D-0437-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
4,176 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0067, Exp Date: 08/31/2026

Recall Number: D-0421-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
9,984 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the product.
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.

Batch or Lot Expiration Information

Lot# Lot SP25A, Exp Date: 09/30/2026

Affected Packages Involved in this Recall

55758-030-05 Artridon Glucosamine

Recall Number: D-0432-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
615, 600 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0008, B0009, B0017, Exp Date: 05/31/2026; Lot B0042, B0043, B0044, Exp Date: 06/30/2026; Lot B0049, B0050, B0051, B0054, B0058, B0059, Exp Date: 07/31/2026; Lot B0061, B0062, B0063, B0064, B0065, B0068, B0069, Exp Date: 08/31/2026

Recall Number: D-0422-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
10,128 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot SP31A, Exp Date: 09/30/2026

Recall Number: D-0435-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
19,500 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0027, B0031, Exp Date: 06/30/2026; Lot B0032, Exp Date: 07/31/2026

Recall Number: D-0436-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
498,960 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0015, B0016, Exp Date: 05/31/2026; Lot B0020, B0021, B0022, Exp Date: 06/30/2026; Lot B0056, B0057, Exp Date: 07/31/2026; Lot B0108, B0109, B0110, Exp Date: 09/30/2026

Recall Number: D-0440-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
160,848 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0032, B0047, B0048, B0055, B0056, Exp Date: 07/31/2026; B0102, B0103, B0104, B0105, B0106, B0107, Exp Date: 09/30/2026

Recall Number: D-0429-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
9,336 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the product.
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.

Batch or Lot Expiration Information

Lot# Lot SP27A, Exp: 09/30/2026

Affected Packages Involved in this Recall

55758-440-02 Rapidol Triple Antibiotic
55758-440-03 Rapidol Triple Antibiotic

Recall Number: D-0430-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
383,904 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0011, B0012, Exp Date: 05/31/2026; Lot B0070, B0074, Exp Date: 08/31/2026; Lot B0075, B0077, B0078, B0079, B0080, B0081, B0082, B0083, B0084, B0085, Exp Date: 09/30/2026

Recall Number: D-0431-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
391,680 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot B0009, B0017, Exp Date: 05/31/2026; Lot B0018, B0019, B0036, B0037, B0038, Exp Date: 06/30/2026; Lot B0049, Exp Date: 07/31/2026; B0063, Exp Date: 08/31/2026

Recall Number: D-0424-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
9,000 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot SP28A, Exp Date: 09/30/2026

Recall Number: D-0426-2025

Reason for Recall
CGMP Deviations
Initiated
04-24-2025
Reported
05-28-2025
Quantity
11,808 Jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KENIL HEALTHCARE PRIVATE LIMITED
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
DE and NC
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the product.
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.

Batch or Lot Expiration Information

Lot# Lot SP30A, Exp Date: 09/30/2026

Affected Packages Involved in this Recall

55758-109-02 Kofal