Sandoz recalls
7 official recalls and safety alerts involving Sandoz since 2021-12, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sandoz or the relevant agency.
- 2026-06-24
USSandoz Inc recalls Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville,…
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2025-09-24
- US
Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by…
cGMP deviations: Temperature excursion during transportation.
- 2025-09-17
- US
- 2025-07-09
- US
Sandoz Inc recalls Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in…
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
- US
Sandoz Inc recalls Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for…
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
- 2022-04-13
- US
Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC…
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- 2021-12-08
- US
Sandoz Inc recalls Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only;…
Temperature Abuse; temperature excursion during shipping