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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 361–380 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.

by Teva Pharmaceuticals USA, Inc

Reason
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Recall initiated
March 17, 2026
Reported by FDA
April 1, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.

by Teva Pharmaceuticals USA, Inc

Reason
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Recall initiated
March 17, 2026
Reported by FDA
April 1, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

by MACLEODS PHARMA USA, INC

Reason
Subpotent Drug
Recall initiated
February 26, 2026
Reported by FDA
April 1, 2026
Distribution
Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

by Chiesi USA, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 17, 2026
Reported by FDA
April 1, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass III

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35

by Radnostix

Reason
Failed Tablet/Capsule Specifications
Recall initiated
February 19, 2026
Reported by FDA
April 1, 2026
Distribution
Nationwide in the US, including Puerto Rico

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Drug Recall Ongoing 2026 recordClass I

Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.

by Cardinal Health 200, LLC

Reason
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Recall initiated
March 2, 2026
Reported by FDA
March 25, 2026
Distribution
Nationwide within the United States, Puerto Rico and Japan.

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Drug Recall Ongoing 2026 recordClass II

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

by Apotex Corp.

Reason
Lack of Assurance of Sterility
Recall initiated
March 5, 2026
Reported by FDA
March 25, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01

by SOMERSET THERAPEUTICS LLC

Reason
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Recall initiated
February 4, 2026
Reported by FDA
March 25, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass III

Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.

by Annora Pharma Private Limited

Reason
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Recall initiated
February 3, 2026
Reported by FDA
March 25, 2026
Distribution
TN

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Drug Recall Ongoing 2026 recordClass II

Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.

by STRIDES PHARMA INC

Reason
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Recall initiated
March 2, 2026
Reported by FDA
March 25, 2026
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Recall initiated
March 9, 2026
Reported by FDA
March 18, 2026
Distribution
Nationwide in the USA

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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.

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

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.