Data Composite

Drug Recalls

Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.

AvKARE

US Class III Ongoing · initiated 2025-06-26

Failed Impurity/Degradation Specifications

Granules Pharmaceuticals Inc.

US Class II Ongoing · initiated 2025-06-24

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Lupin Pharmaceuticals Inc.

US Class II Ongoing · initiated 2025-06-20

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg h…

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-06-20

Subpotent Drug: Assay below the approved specification

The Harvard Drug Group LLC

US Class II Ongoing · initiated 2025-06-19

Defective container; blister packaging inadequately sealed.

The Harvard Drug Group LLC

US Class II Ongoing · initiated 2025-06-19

Defective container; blister packaging inadequately sealed.

Gamunex solution

Canada Type III Ongoing · initiated 2025-06-19

Adverse reaction. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health c…

Accel-Ondansetron ODT 4 & 8 mg

Canada Type I Ongoing · initiated 2025-06-18

Product quality. Return the affected products to your local pharmacy for a replacement, and for proper disposal. If you are unsure whether your product is affec…

Teva-Piroxicam 10 mg capsule

Canada Type II Ongoing · initiated 2025-06-18

Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…

Weiteling tablet

Canada Type III Ongoing · initiated 2025-06-17

Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…

JuHong TanKe JianGao liquid

Canada Type III Ongoing · initiated 2025-06-17

Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…

B BRAUN MEDICAL INC

US Class II Ongoing · initiated 2025-06-16

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Qualgen, LLC

US Class III Ongoing · initiated 2025-06-16

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-06-16

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60…

Kimmtrak Solution

Canada Type II Ongoing · initiated 2025-06-16

Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…

Orient Pharma Co., Ltd. Yunlin Plant

US Class III Ongoing · initiated 2025-06-11

Failed Impurities/Degradation Specifications.

Orient Pharma Co., Ltd. Yunlin Plant

US Class III Ongoing · initiated 2025-06-11

Failed Impurities/Degradation Specifications.

Macleods Pharmaceuticals Ltd

US Class III Ongoing · initiated 2025-06-11

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

IMMUNOCORE, LLC

US Class II Ongoing · initiated 2025-06-10

Subpotent Drug