--- title: "Sandoz Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Sandoz Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/sandoz-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Sandoz Inc recall records **5** reported ongoing 9 records in this archive. Latest source date Jun 1, 2026. 2 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 1, 2026 FDA drug enforcement ### [Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31](https://isitonrecall.com/recall/fda-drug-d-0608-2026-focalin-xr-dexmethylphenidate-hcl-5-mg-30-extended-release-capsules-per-bottle-rx-only-manufactured/) Labeling: Incorrect or Missing Lot and/or Exp Date Class III Reported ongoing Distribution: U.S. Nationwide [Official source for Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manuf...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0608-2026%22) Sep 5, 2025 FDA drug enforcement ### [Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Pr...](https://isitonrecall.com/recall/fda-drug-d-0651-2025-cyclophosphamide-injection-500-mg-5-ml-100-mg-ml-hazardous-drug-rx-only-sterile-5ml-multiple-dose-vi/) cGMP deviations: Temperature excursion during transportation. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multipl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0651-2025%22) Aug 13, 2025 FDA drug enforcement ### [Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princ...](https://isitonrecall.com/recall/fda-drug-d-0626-2025-ciprofloxacin-0-3-and-dexamethasone-0-1-otic-suspension-rx-only-for-use-in-ears-only-manufactured-by/) Temperature Abuse Class II Reported ongoing Distribution: Product was distributed to one consignee in CA. [Official source for Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufact...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0626-2025%22) Jul 15, 2025 FDA company announcement ### [Sandoz: Cefazolin for Injection, USP, 1 gm vial](https://isitonrecall.com/recall/fdapress-cccec4247cbd82f2-sandoz-cefazolin-for-injection-usp-1-gm-vial/) Vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection Not supplied Published notice; closure not supplied Distribution: Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distrib... [Official source for Sandoz: Cefazolin for Injection, USP, 1 gm vial](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-sandoz-inc-issues-voluntary-nationwide-recall-expansion-one-additional-lot-cefazolin) Jun 27, 2025 FDA drug enforcement ### [Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781...](https://isitonrecall.com/recall/fda-drug-d-0569-2025-cefazolin-for-injection-usp-1-gram-per-vial-sterile-for-intramuscular-or-intravenous-use-rx-only-man/) 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 Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0569-2025%22) Jun 27, 2025 FDA drug enforcement ### [Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Prin...](https://isitonrecall.com/recall/fda-drug-d-0570-2025-buffered-penicillin-g-potassium-for-injection-usp-20-000-000-units-20-million-units-for-iv-use-steri/) 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 Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV us...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0570-2025%22) Jun 27, 2025 FDA company announcement ### [Sandoz: Cefazolin for Injection, USP, 1 gm vial](https://isitonrecall.com/recall/fdapress-a63832019d2eba24-sandoz-cefazolin-for-injection-usp-1-gm-vial/) Potential Presence of Penicillin G Potassium Injection Vial Not supplied Published notice; closure not supplied Distribution: Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distrib... [Official source for Sandoz: Cefazolin for Injection, USP, 1 gm vial](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging) Mar 21, 2022 FDA drug enforcement ### [Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.](https://isitonrecall.com/recall/fda-drug-d-0753-2022-orphenadrine-citrate-extended-release-tablets-usp-100-mg-rx-only-100-tablets-manufactured-by-sandoz/) CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Class II Reported terminated Distribution: Nationwide [Official source for Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0753-2022%22) Nov 17, 2021 FDA drug enforcement ### [Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz ...](https://isitonrecall.com/recall/fda-drug-d-0286-2022-enoxaparin-sodium-injection-usp-40-mg-0-4-ml-single-dose-syringes-with-automatic-safety-device-for-s/) Temperature Abuse; temperature excursion during shipping Class I Reported completed Distribution: Nationwide in the US [Official source for Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0286-2022%22) ## Reasons in these listed records - Labeling: Incorrect or Missing Lot and/or Exp Date - cGMP deviations: Temperature excursion during transportation. - Temperature Abuse - Vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection These examples come from this result page and are not a ranking of every recall reason. ## Checking Sandoz Inc ### Is there a recall on sandoz inc right now? This archive contains 9 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Sandoz Inc](https://isitonrecall.com/check/?q=Sandoz%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)