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Sandoz Inc FDA Recalls
7 recalls on file across drugs, 3 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMClass IIIJun 1, 2026Labeling: Incorrect or Missing Lot and/or Exp Date |
| Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, ManufacturClass IISep 5, 2025cGMP deviations: Temperature excursion during transportation |
| Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis ManufClass IIAug 13, 2025Temperature Abuse |
| Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, MaClass IJun 27, 2025Labeling: Label Mix-Up; Some vials of Cefazolin for Injectio |
| Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by SClass IJun 27, 2025Labeling: Label Mix-Up; cartons of Cefazolin for Injection, |
| Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,Class IIMar 21, 2022CGMP Deviations:Nitrosamine impurity (NMOA) above the accept |
| Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous InjeClass INov 17, 2021Temperature Abuse; temperature excursion during shipping |