18,003 recalls, newest first
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Lack of Assurance of Sterility; improperly crimped fliptop vials
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.