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.
ICU Medical, Inc.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The cor…
Johnson, S C and Son, Inc
Chemical Contamination
World Perfumes Inc.
Defective Container: broken or leaking bottles.
Wuxi Medical lnstrument Factory Co., Ltd.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Padagis US LLC
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications
BIOV Health Calcium (Carbonate) 300 mg Chewable Tablets
Product quality. Verify if your product is affected.Stop taking the affected product and consult your healthcare provider for any health concerns.If you have an…
SENNA Tablet USP ; JAMP Senna ; Jamp - SENNA
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…
AvKARE
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 1…
Ferinject
Labelling. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns…
Lacosamide Injection 10mg/ml
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…
Fagron Compounding Services
Lack of Assurance of Sterility
Alvogen, Inc
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Direct Rx
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
APO-QUETIAPINE XR
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…
PMS-FLUOXETINE 10 mg
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
Failed Dissolution Specifications.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.