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.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Terminated · initiated 2024-11-07

Failed Impurity/Degradation Specifications

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Terminated · initiated 2024-11-07

Failed Impurity/Degradation Specifications

Aurobindo Pharma USA Inc

US Class II Ongoing · initiated 2024-11-07

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Aurobindo Pharma USA Inc

US Class II Ongoing · initiated 2024-11-07

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Aurobindo Pharma USA Inc

US Class II Ongoing · initiated 2024-11-07

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Uceris Rectal Foam

Canada Type II Ongoing · initiated 2024-11-07

Product safety. Verify if your product is affected.Consult your healthcare provider about an alternative product for your condition, or for any health concerns.…

Trinity Gold Nutrition

US Class II Ongoing · initiated 2024-11-06

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.

Tailstorm Health INC

US Class II Terminated · initiated 2024-11-06

Lack of Sterility Assurance

Midlab Incorporated

US Class II Ongoing · initiated 2024-11-06

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated

US Class II Ongoing · initiated 2024-11-06

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated

US Class II Ongoing · initiated 2024-11-06

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated

US Class II Ongoing · initiated 2024-11-06

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated

US Class II Ongoing · initiated 2024-11-06

cGMP Deviations: Out of specification results for micro in hand soap products.

Midlab Incorporated

US Class II Ongoing · initiated 2024-11-06

cGMP Deviations: Out of specification results for micro in hand soap products.

Pregnancy Multivitamin, Pregnancy Multivitamin Folic 5

Canada Type II Ongoing · initiated 2024-11-06

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

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class III Terminated · initiated 2024-11-05

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

COMPLETE 6000 WIPES

Canada Type II Ongoing · initiated 2024-11-05

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…

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Florabile

Canada Type II Ongoing · initiated 2024-11-04

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…

Dead Down Wind Broad Spectrum SPF 30 Odourless Lip Balm

Canada Type III Ongoing · initiated 2024-11-04

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

JR Watkins

US Class II Terminated · initiated 2024-11-01

cGMP Deviations

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.