Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
Source: CPSC Recall #18183
Recall Date
2018-07-06
Manufacturer
Sandoz Inc., of Princeton, N.J., Novartis Pharmaceuticals Corp., of East Hanover, N.J.
Units Affected
About 470,000
Products Involved
Blister packages of prescription medication
Hazard
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.
Remedy
Consumers should immediately secure the blister cards to keep them out of the sight and reach of children and contact Novartis or Sandoz for further instructions. Novartis and Sandoz advise that consumers should continue to use the medication as directed once the blister packages are secured.
Reported Injuries
The firms have received one report of a child ingesting haloperidol from a blister pack.
Sold At
Clinics and pharmacies nationwide as a prescribed medicine from September 2016 to June 2018, at prices varying based on quantities prescribed, health insurance terms and other factors.
Manufactured In
ItalyIrelandUnited KingdomIsraelSpainSingaporeIndiaCroatiaUnited States
Full Recall Description
This recall involves blister packages of prescription drugs from Novartis and Sandoz. The drugs are packaged with 3 to 10 tablets per blister card. The recalled Novartis prescription blister packages have "Novartis," the name of the drug, dosage, NDC, lot number and expiration date printed on the cartons and the blister cards. The recall includes the following: Recalled Novartis Prescription Drugs NDC Numbers Tablet Strength Carton Configuration Lot Numbers Expiration Date Zofran ODT® 0078-0679-61 0078-0679-19 4 mg 30 count: 3 cards with 10 tablets each 1657088 Dec 2019 Zofran ODT® 0078-0680-61 0078-0680-19 8 mg 30 count: 3 cards with 10 tablets each 1641546 Oct 2019 Entresto® (sacubitril/valsartan) 0078-0659-61 0078-0659-35 24 mg/ 26 mg 100 count: 10 cards with 10 tablets each FX000005 FX000004 FX000003 F0010 F0009 F0007 Apr 2020 Apr 2020 Sep 2019 Nov 2018 Aug 2018 Jul 2018 Entresto® (sacubitril/valsartan) 0078-0777-61 0078-0777-35 49 mg/ 51 mg 100 count: 10 cards with 10 tablets each FX000001 F0006 F0005 F0004 Dec 2019 Oct 2019 Aug 2019 Oct 2018 Entresto® (sacubitril/valsartan) 0078-0696-61 0078-0696-35 97 mg/ 103 mg 100 count: 10 cards with 10 tablets each FX000002 F0007 F0006 F0005 F0004 Mar 2020 Feb 2020 Dec 2019 Dec 2018 Oct 2018 The recalled Sandoz prescription blister packages have "Sandoz," the name of the drug, dosage, NDC and lot number printed on the cartons and the blister cards. Lot numbers are listed at www.us.sandoz.com/patients-customers/product-safety-notice
Data source: U.S. Consumer Product Safety Commission (CPSC) via SaferProducts.gov.
For the most current recall information, check directly with CPSC or the manufacturer.
Last verified: 2026-03-28