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Home > Recalled Products > Food & Supplements (Packaging ONLY) > Medication & First Aid > Medication > Blister Packages of Prescription Medication

Recall: Blister Packages of Prescription Medication

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On 2018-07-06, the Consumer Product Safety Commission (CPSC) published a recall regarding Blister Packages of Prescription Medication due to a potential Failure to Protect hazard. This product sold new beginning in September 2016.

About 500,000 units are involved in this prescription drug blister packages recall. Learn more and find out what to do if you own this product below.

This was the 2nd recall of products in the Medication category in 2018.

Check My Prescription Drug Blister Packages   |   See Other Recalled Medication

Blister Packages of Prescription Medication
Image of Recalled Donepezil ODT 10mg 607652
Note: The recalling company may not have provided images for every model. Please review the detailed description below.

Company Contact Information:

Phone: 888-669-6682

Do you work for a company involved with this recall? Contact us to learn how you can control data, information and ads shown on this page.

What is the problem?

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

How can I tell if I own this product?

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 2020Apr 2020Sep 2019Nov 2018Aug 2018Jul 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 2019Oct 2019Aug 2019Oct 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 2020Feb 2020Dec 2019Dec 2018Oct 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-notices. The recall includes the following:
Recalled Sandoz Prescription Drugs Tablet Strength NDC Numbers Carton Configuration
Azithromycin Tablets 250 mg 0781-5776-06
0781-5776-69
50 count: 5 cards with 10 tablets each
Donepezil ODT Tablets 5 mg 0781-5276-06
0781-5276-64
30 count: 3 cards with 10 tablets each
Donepezil ODT Tablets 10 mg 0781-5277-06
0781-5277-64
30 count: 3 cards with 10 tablets each
Haloperidol Tablets 0.5 mg 0781-1391-13 100 count: 10 cards with 10 tablets each
Haloperidol Tablets 1 mg 0781-1392-13 100 count: 10 cards with 10 tablets each
Haloperidol Tablets 2 mg 0781-1393-13 100 count: 10 cards with 10 tablets each
Haloperidol Tablets 5 mg 0781-1396-13 100 count: 10 cards with 10 tablets each
Haloperidol Tablets 10 mg 0781-1397-13 100 count: 10 cards with 10 tablets each
Imipramine HCl Tablets 25 mg 0781-1764-13 100 count: 10 cards with 10 tablets each
Imipramine HCl Tablets 50 mg 0781-1766-13 100 count: 10 cards with 10 tablets each
Isosorbide Dinitrate (ISDN) Tablets 10 mg 0781-1556-13 100 count: 10 cards with 10 tablets each
Isosorbide Dinitrate (ISDN) Tablets 20 mg 0781-1695-13 100 count: 10 cards with 10 tablets each
Naratriptan Tablets 2.5 mg 0781-5527-06
0781-5527-37
9 count: 1 card with 9 tablets
Ondansetron Tablets 8 mg 0781-1681-33 3 count: 1 card with 3 tablets
Ondansetron ODT 4 mg 0781-5238-06
0781-5238-64
30 count: 3 cards with 10 tablets each
Ondansetron ODT 8 mg 0781-5239-06
0781-5239-64
30 count: 3 cards with 10 tablets each
Ondansetron ODT 8 mg 0781-5239-06
0781-5239-80
10 count: 1 card with 10 tablets
Perphenazine Tablets 2 mg 0781-1046-13 100 count: 10 cards with 10 tablets each
Perphenazine Tablets 4 mg 0781-1047-13 100 count: 10 cards with 10 tablets each
Perphenazine Tablets 8 mg 0781-1048-13 100 count: 10 cards with 10 tablets each
Risperidone ODT 0.5 mg 0781-5310-06
0781-5310-08
28 count: 7 cards with 4 tablets each
Risperidone ODT 1 mg 0781-5311-06
0781-5311-08
28 count: 7 cards with 4 tablets each
Risperidone ODT 2 mg 0781-5312-06
0781-5312-08
28 count: 7 cards with 4 tablets each
Risperidone ODT 3 mg 0781-5313-06
0781-5313-08
28 count: 7 cards with 4 tablets each
Risperidone ODT 4 mg 0781-5314-06
0781-5314-08
28 count: 7 cards with 4 tablets each

These items were sold new+ 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.

What should I do if I own this recalled product?

First, stop using the item.

Then, add the item to a free, private Items I Own account. This will enable you to easily access the CPSC and recalling company's remedy instructions as well as track your progress toward getting the item returned or fixed. Click "I Own THIS Item" to continue.

The CPSC provides the following remedy information:

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.

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. ETor 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."

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Incidents & Injuries Reported as of Recall Date

The firms have received one report of a child ingesting haloperidol from a blister pack.

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+WeMakeItSafer cautions consumers that recalled items may have been acquired at different locations, prices and times than specified in the CPSC recall announcement. This is especially true for items purchased in online marketplaces, resale shops or yard sales. More information may be available at CPSC.gov.

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Sources may include: Consumer Product Safety Commission (CPSC), Health Canada and companies involved with this or a related recall.

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