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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 301–320 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.

by Dabur India Limited

Reason
CGMP Deviations; deficiencies observed during FDA inspection
Recall initiated
June 2, 2026
Reported by FDA
June 24, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10

by Inventia Healthcare Limited

Reason
Failed Dissolution Specifications
Recall initiated
June 5, 2026
Reported by FDA
June 24, 2026
Distribution
U.S. Nationwide.

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Drug Recall Ongoing 2026 recordClass III

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

by Sandoz Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
June 1, 2026
Reported by FDA
June 24, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.

by Keystone Industries

Reason
Defective container:may contain bottles with incomplete seals
Recall initiated
May 21, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05

by Par Health USA, LLC

Reason
Crystallization; identified as Buprenorphine free base
Recall initiated
June 12, 2026
Reported by FDA
June 24, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.

by Ajanta Pharma USA Inc

Reason
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Recall initiated
May 27, 2026
Reported by FDA
June 24, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

by IntegraDose Compounding Services LLC

Reason
Subpotent Drug
Recall initiated
May 18, 2026
Reported by FDA
June 24, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.

by PAI Holdings LLC

Reason
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Recall initiated
May 15, 2026
Reported by FDA
June 24, 2026
Distribution
U.S.A. Nationwide

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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