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.
Jamp Amoxi Clav Suspension
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…
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability s…
ENDO USA, Inc.
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
TEVA-Codeine Tablets
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…
Hikma Injectables USA Inc
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA Inc
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
AvKARE
LABELING: LABEL MIX-UP
AvKARE
LABELING: LABEL MIX-UP
Granules Pharmaceuticals Inc.
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Eugia US LLC
CGMP Deviations
Alcon Research LLC
Non-Sterility
Amerisource Health Services LLC
Failed Dissolution Specifications:
SOMERSET THERAPEUTICS LLC
Failed Impurities/Degradation Specifications
FDC Limited
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
SHOPPERS- PLAZA
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
ANTIHISTAMINE ORAL
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…
Amerisource Health Services LLC
Presence of Foreign Tablets/Capsules
Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
GNMart LLC
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Buy-Herbal
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Akron Pharma, Inc.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.