Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
Home product recall 18-183. Announced by CPSC on Jul 6, 2018.
Watch and the shortlist are kept with a free account, on every device. Your watch list. CPSC’s own notice is on cpsc.gov.
The short answer
Announced by CPSC on Jul 6, 2018. Copied from CPSC on Oct 19, 2026.
- New Instructions what’s offered
- About 470,000 units, as CPSC gives them
- Not said injuries, in the notice
Every line below is in CPSC’s own words, with its source beside it.
What’s wrong with it?
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
What should you do?
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.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
- What the company offers to fix a recalled product or vehicle: a repair, a replacement or a refund, as the recall notice says. For a vehicle, dealers make the safety repair free. Follow the notice’s own steps, or contact the company it names. Source: CPSC; NHTSA (49 U.S.C. 30120).: new instructions.
- How to reach the firm: 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.”
Which ones are recalled?
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-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
About 470,000 units, as CPSC gives them.
Blister packages of prescription medication.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
CPSC’s photos
CPSC shows 5 photos on its notice. Hearth Record doesn’t copy them; each opens on cpsc.gov.
Who made and sold it?
- Distributed by Sandoz Inc., Princeton, N.J.
- Distributed by Novartis Pharmaceuticals Corp., East Hanover, N.J.
- 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.
- Made in Croatia, India, Ireland, Israel, Italy, Singapore, Spain, United Kingdom and United States, as the notice gives it.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
Was anyone hurt?
The firms have received one report of a child ingesting haloperidol from a blister pack.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
What the record doesn’t say
- The notice lists no UPCs, so check the model, the description and the photos.
- The notice lists no model numbers in a field of their own; its description may give them.
- How many have been returned or fixed isn’t in the notice.
Hearth Record wrote these lines.
Sources
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U.S. Consumer Product Safety Commission, Recalls API.
Checked Oct 19, 2026. Updated daily. Public domain (U.S. Government work). CPSC asks to be credited, and that no endorsement be implied.
Recalls of kids’ and home products are from the U.S. Consumer Product Safety Commission (CPSC). CPSC does not endorse Hearth Record. Copied on Oct 19, 2026.