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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskCPSC
Medications & Supplements/Prescription Drugs

Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements

Agency Publication Date: July 6, 2018
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Summary

Novartis and Sandoz are recalling approximately 470,000 units of various prescription drug blister packages because the packaging is not child-resistant as required by law. The medications affected include several common drugs like Zofran ODT (ondansetron), Entresto (sacubitril/valsartan), and various generic tablets such as Donepezil, Haloperidol, and Risperidone. These medications were sold at clinics and pharmacies nationwide from September 2016 through June 2018. Consumers should immediately secure the affected medications and contact the manufacturers for further instructions.

Risk

The packaging fails to meet child-resistant closure requirements, posing a serious poisoning risk if the medication is accessed and swallowed by a child. There has been one report of a child ingesting haloperidol from one of these blister packs.

What You Should Do

  1. Check your prescription medications to see if they are from Novartis or Sandoz and packaged in blister cards (cards where tablets are pushed out through foil).
  2. If you have an affected medication, immediately secure the blister cards in a location that is completely out of the sight and reach of children, such as a locked cabinet.
  3. Identify your medication by checking the drug name, dosage, and NDC numbers on the carton or blister card against the list of affected products, including Zofran ODT (NDC 0078-0679-61, 0078-0680-61), Entresto (NDC 0078-0659-61, 0078-0777-61, 0078-0696-61), and various Sandoz generics like Donepezil ODT, Naratriptan, and Risperidone ODT.
  4. Do NOT stop taking your medication; Novartis and Sandoz advise that you should continue to use the medicine as directed by your doctor once the blister packages are secured safely away from children.
  5. Contact Sandoz and Novartis at 888-669-6682 (Monday–Friday 8 a.m. to 8 p.m. ET, or weekends 9 a.m. to 6 p.m. ET) or visit www.us.sandoz.com or www.pharma.us.novartis.com for further instructions on the recall.
  6. For additional information, you can contact the CPSC Hotline at 800-638-2772.

Your Remedy Options

📋New Instructions

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.

Contact: Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8 a.m. to 8 p.m. ET and Saturday and Sunday, 9 a.m. to 6 p.m. ET or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices,” or at www.pharma.us.novartis.com and click on banner “Novartis recalls select product blister packs.”

Affected Products

Product: Zofran ODT (ondansetron) 4 mg (30 count: 3 cards with 10 tablets each)
Model:
0078-0679-61
0078-0679-19
Lot Numbers:
1657088 (Exp Dec 2019)
Date Ranges: December 2019
Product: Zofran ODT (ondansetron) 8 mg (30 count: 3 cards with 10 tablets each)
Model:
0078-0680-61
0078-0680-19
Lot Numbers:
1641546 (Exp Oct 2019)
Date Ranges: October 2019
Product: Entresto (sacubitril/valsartan) 24 mg/ 26 mg (100 count: 10 cards with 10 tablets each)
Model:
0078-0659-61
0078-0659-35
Lot Numbers:
FX000005 (Exp Apr 2020)
FX000004 (Exp Apr 2020)
FX000003 (Exp Sep 2019)
F0010 (Exp Nov 2018)
F0009 (Exp Aug 2018)
F0007 (Exp Jul 2018)
Date Ranges: July 2018 - April 2020
Product: Entresto (sacubitril/valsartan) 49 mg/ 51 mg (100 count: 10 cards with 10 tablets each)
Model:
0078-0777-61
0078-0777-35
Lot Numbers:
FX000001 (Exp Dec 2019)
F0006 (Exp Oct 2019)
F0005 (Exp Aug 2019)
F0004 (Exp Oct 2018)
Date Ranges: October 2018 - December 2019
Product: Entresto (sacubitril/valsartan) 97 mg/ 103 mg (100 count: 10 cards with 10 tablets each)
Model:
0078-0696-61
0078-0696-35
Lot Numbers:
FX000002 (Exp Mar 2020)
F0007 (Exp Feb 2020)
F0006 (Exp Dec 2019)
F0005 (Exp Dec 2018)
F0004 (Exp Oct 2018)
Date Ranges: October 2018 - March 2020
Product: Azithromycin Tablets 250 mg (50 count: 5 cards with 10 tablets each)
Model:
0781-5776-06
0781-5776-69
Product: Donepezil ODT Tablets 5 mg (30 count: 3 cards with 10 tablets each)
Model:
0781-5276-06
0781-5276-64
Product: Donepezil ODT Tablets 10 mg (30 count: 3 cards with 10 tablets each)
Model:
0781-5277-06
0781-5277-64
Product: Haloperidol Tablets 0.5 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1391-13
Product: Haloperidol Tablets 1 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1392-13
Product: Haloperidol Tablets 2 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1393-13
Product: Haloperidol Tablets 5 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1396-13
Product: Haloperidol Tablets 10 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1397-13
Product: Imipramine HCl Tablets 25 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1764-13
Product: Imipramine HCl Tablets 50 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1766-13
Product: Isosorbide Dinitrate (ISDN) Tablets 10 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1556-13
Product: Isosorbide Dinitrate (ISDN) Tablets 20 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1695-13
Product: Naratriptan Tablets 2.5 mg (9 count: 1 card with 9 tablets)
Model:
0781-5527-06
0781-5527-37
Product: Ondansetron Tablets 8 mg (3 count: 1 card with 3 tablets)
Model:
0781-1681-33
Product: Ondansetron ODT 4 mg (30 count: 3 cards with 10 tablets each)
Model:
0781-5238-06
0781-5238-64
Product: Ondansetron ODT 8 mg (30 count: 3 cards with 10 tablets each)
Model:
0781-5239-06
0781-5239-64
Product: Ondansetron ODT 8 mg (10 count: 1 card with 10 tablets)
Model:
0781-5239-06
0781-5239-80
Product: Perphenazine Tablets 2 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1046-13
Product: Perphenazine Tablets 4 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1047-13
Product: Perphenazine Tablets 8 mg (100 count: 10 cards with 10 tablets each)
Model:
0781-1048-13
Product: Risperidone ODT 0.5 mg (28 count: 7 cards with 4 tablets each)
Model:
0781-5310-06
0781-5310-08
Product: Risperidone ODT 1 mg (28 count: 7 cards with 4 tablets each)
Model:
0781-5311-06
0781-5311-08
Product: Risperidone ODT 2 mg (28 count: 7 cards with 4 tablets each)
Model:
0781-5312-06
0781-5312-08
Product: Risperidone ODT 3 mg (28 count: 7 cards with 4 tablets each)
Model:
0781-5313-06
0781-5313-08
Product: Risperidone ODT 4 mg (28 count: 7 cards with 4 tablets each)
Model:
0781-5314-06
0781-5314-08

Product Images

Donepezil ODT 10 mg

Donepezil ODT 10 mg

Naratriptan 2.5 mg tablets

Naratriptan 2.5 mg tablets

Ondansetron Tablets 8 mg.

Ondansetron Tablets 8 mg.

Risperidone ODT 2 mg.

Risperidone ODT 2 mg.

Zofran® ODT 4 mg.

Zofran® ODT 4 mg.

Additional Information

Agency: Consumer Product Safety Commission (CPSC)
Recall ID: 18183
Status: Active
Sold By: 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.
Distributor: Sandoz Inc., of Princeton, N.J.; Novartis Pharmaceuticals Corp., of East Hanover, N.J.
Manufactured In: Croatia, India, Ireland, Israel, Italy, Singapore, Spain, United Kingdom, United States
Units Affected: About 470,000
Distributed To: Nationwide
Contact: Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8 a.m. to 8 p.m. ET and Saturday and Sunday, 9 a.m. to 6 p.m. ET or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices,” or at www.pharma.us.novartis.com and click on banner “Novartis recalls select product blister packs.”
Agency Last Updated: July 6, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response