Sandoz recalls
FDA enforcement reports naming Sandoz Inc as the recalling firm.
- Recall reports
- 57
- Class I (serious)
- 4
- Most recent report
- Jun 24, 2026
- Jun 24, 2026Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx o…Drug · Sandoz IncLabeling: Incorrect or Missing Lot and/or Exp DateClass III
- Sep 24, 2025Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5…Drug · Sandoz InccGMP deviations: Temperature excursion during transportation.Class II
- Sep 17, 2025Ciprofloxacin 0Drug · Sandoz IncTemperature AbuseClass II
- Jul 9, 2025Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units),…Drug · Sandoz IncLabeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million UnitClass I
- Jul 9, 2025Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenou…Drug · Sandoz IncLabeling: 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 CefozalinClass I
- Apr 13, 2022Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufa…Drug · Sandoz, IncCGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.Class II
- Dec 8, 2021Enoxaparin Sodium Injection, USP, 40 mg/0Drug · Sandoz IncTemperature Abuse; temperature excursion during shippingClass I
- May 13, 2020Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 m…Drug · Sandoz, IncDefective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple VitaminsClass II
- Nov 6, 2019Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Ste…Drug · Sandoz IncLabeling: Incorrect or missing package insert.Class III
- Nov 6, 2019Bimatoprost Ophthalmic Solution 0Drug · Sandoz IncLabeling: Incorrect or missing package insert.Class III
- Gatifloxacin Ophthalmic Solution 0
- Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sand…
- Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sand…
- Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by San…
- Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-coun…
- Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: San…
- Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx…
- Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-cap…
- Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sa…
- Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sand…
- Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: San…
- Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx on…
- Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged…
- Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01…
- Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles,…
- Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manuf…
- Transderm Scop (scopolamine) Transdermal System, 1
- Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-…
- Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by San…
- Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I
- L-Cysteine Hydrochloride Injection, USP, 0
- L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (N…
- Transderm Scop (scopolamine) Transdermal System, 1
- Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66…
- Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01),…
- Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in…
- Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in…
- Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc
- Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (…
- Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and…
- Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Pri…
- candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for San…
- Alprazolam Tablets, USP, 0
- Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0…
- Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only
- Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12
- Tacrolimus Capsules, USP, 0
- Bumetanide Tablets USP 0
- Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0
- Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose…
- Estarylla (Norgestimate and Ethinyl Estradiol) Tablets
- Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use v…
- Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc
- Syeda (drospirenone and ethinyl estradiol), 3 mg/0
- Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in…
- Pramipexole Dihydrochloride Tablets, 0
- Pramipexole Dihydrochloride Tablets, 0
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