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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 1,161–1,180 of 18,047 drug recalls

Drug Recall Terminated Historical recordClass II

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

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Terminated Historical recordClass II

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.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Recall initiated
April 24, 2025
Reported by FDA
May 28, 2025
Distribution
DE and NC

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.

by Empower Clinic Services, LLC dba Empower Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
May 2, 2025
Reported by FDA
May 21, 2025
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.

by L'Oreal USA

Reason
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Recall initiated
March 5, 2025
Reported by FDA
May 21, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit).

by L'Oreal USA

Reason
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Recall initiated
March 5, 2025
Reported by FDA
May 21, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.

by L'Oreal USA

Reason
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Recall initiated
March 5, 2025
Reported by FDA
May 21, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01

by BSO LLC

Reason
Presence of Particulate Matter: Glass particles were found in pellet vials.
Recall initiated
April 28, 2025
Reported by FDA
May 14, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01

by BSO LLC

Reason
Presence of Particulate Matter: Glass particles were found in pellet vials.
Recall initiated
April 28, 2025
Reported by FDA
May 14, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01

by BSO LLC

Reason
Presence of Particulate Matter: Glass particles were found in pellet vials.
Recall initiated
April 28, 2025
Reported by FDA
May 14, 2025
Distribution
Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.

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