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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 381–400 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

by HTO Nevada Inc. dba Kirkman

Reason
Stability Data Does Not Support Expiry Date.
Recall initiated
February 18, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

by HTO Nevada Inc. dba Kirkman

Reason
Stability Data Does Not Support Expiry Date.
Recall initiated
February 18, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

by HTO Nevada Inc. dba Kirkman

Reason
Stability Data Does Not Support Expiry Date.
Recall initiated
February 18, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.

by Rising Pharma Holding, Inc.

Reason
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Recall initiated
March 3, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

by The Harvard Drug Group LLC

Reason
Defective container; inadequately sealed blister packaging.
Recall initiated
February 17, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide US.

View recall →

Drug Recall Ongoing 2026 recordClass III

Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17

by Cipla USA, Inc.

Reason
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Recall initiated
February 18, 2026
Reported by FDA
March 11, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17

by Cipla USA, Inc.

Reason
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Recall initiated
February 18, 2026
Reported by FDA
March 11, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.

by Harbin Jixianglong Biotech Co., Ltd.

Reason
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Recall initiated
February 13, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China

by Harbin Jixianglong Biotech Co., Ltd.

Reason
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Recall initiated
February 13, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.

by ACME UNITED CORPORATION

Reason
CGMP Deviations
Recall initiated
January 20, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

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.