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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 161–180 of 17,898 drug recalls

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 →

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.

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 →

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.

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 →

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.

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 →

Drug Recall Ongoing 2026 recordClass II

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Recall initiated
May 27, 2026
Reported by FDA
June 24, 2026
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass I

BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.

by BEEKEEPER'S NATURALS USA INC.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
June 1, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States.

View recall →

Drug Recall Ongoing 2026 recordClass II

Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Recall initiated
May 29, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Recall initiated
June 1, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass I

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

by Haleon US Holdings LLC

Reason
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Recall initiated
June 4, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.

by Golden State Medical Supply Inc.

Reason
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Recall initiated
May 29, 2026
Reported by FDA
June 17, 2026
Distribution
Within the U.S Market.

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.