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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 521–540 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.

by MYLAN PHARMACEUTICALS INC

Reason
Failed Dissolution Specifications
Recall initiated
February 24, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass I

MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

by StuffbyNainax

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Recall initiated
December 15, 2025
Reported by FDA
March 11, 2026
Distribution
Product was distributed to 4 customers in the US.

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Drug Recall Ongoing 2026 recordClass I

Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0

by Mohamed Hagar

Reason
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Recall initiated
October 8, 2025
Reported by FDA
March 11, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.

by New Life Pharma LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 26, 2026
Reported by FDA
March 11, 2026
Distribution
OH

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Drug Recall Ongoing 2026 recordClass II

Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.

by New Life Pharma LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 26, 2026
Reported by FDA
March 11, 2026
Distribution
OH

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Drug Recall Ongoing 2026 recordClass II

Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

by New Life Pharma LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 26, 2026
Reported by FDA
March 11, 2026
Distribution
OH

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Drug Recall Ongoing 2026 recordClass II

Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.

by New Life Pharma LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 26, 2026
Reported by FDA
March 11, 2026
Distribution
OH

View recall →

Drug Recall Ongoing 2026 recordClass II

Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.

by Radnostix

Reason
Presence of Particulate Matter: Due to production issues
Recall initiated
January 26, 2026
Reported by FDA
March 11, 2026
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Ongoing 2026 recordClass I

SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China

by ANTHONY TRINH, 123Herbals LLC

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Recall initiated
October 20, 2025
Reported by FDA
March 11, 2026
Distribution
USA nationwide

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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

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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.

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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 →

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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