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.

Pharmadel, LLC

US Class II Terminated · initiated 2025-04-15

cGMP deviations

Pharmadel, LLC

US Class II Terminated · initiated 2025-04-15

cGMP deviations

Pharmadel, LLC

US Class II Terminated · initiated 2025-04-15

cGMP deviations

OurPharma LLC

US Class III Terminated · initiated 2025-04-15

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

Pharmadel, LLC

US Class II Terminated · initiated 2025-04-15

cGMP deviations

Nubratori, Inc

US Class II Ongoing · initiated 2025-04-15

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the oute…

Apollo Care, LLC

US Class II Ongoing · initiated 2025-04-15

Lack of Assurance of Sterility

Life Brand Timed Release Melatonin 10mg

Canada Type II Ongoing · initiated 2025-04-15

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

Riva Acetaminophen Caplet 500mg

Canada Type III Ongoing · initiated 2025-04-15

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 c…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Ongoing · initiated 2025-04-14

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Breckenridge Pharmaceutical, Inc

US Class II Ongoing · initiated 2025-04-14

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Breckenridge Pharmaceutical, Inc

US Class II Ongoing · initiated 2025-04-14

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

SAINI TRADE INC

US Class I Ongoing · initiated 2025-04-14

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sild…

SAINI TRADE INC

US Class I Ongoing · initiated 2025-04-14

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

SAINI TRADE INC

US Class I Ongoing · initiated 2025-04-14

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

SAINI TRADE INC

US Class I Ongoing · initiated 2025-04-14

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

SAINI TRADE INC

US Class I Ongoing · initiated 2025-04-14

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

NRA-Quetiapine XR

Canada Type II Ongoing · initiated 2025-04-11

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 c…

Eugia US LLC

US Class II Ongoing · initiated 2025-04-10

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Lupin Pharmaceuticals Inc.

US Class II Terminated · initiated 2025-04-10

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 1…

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-04-10

Subpotent

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-04-10

Subpotent

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-04-10

Subpotent

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2025-04-10

Subpotent

Apipharma

US Class II Ongoing · initiated 2025-04-09

CGMP Deviations