Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Home product recall 20-091. Announced by CPSC on Mar 18, 2020.
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 Mar 18, 2020. Copied from CPSC on Oct 19, 2026.
- New Instructions or Repair what’s offered
- About 73,000 units, as CPSC gives them
- None injuries, CPSC’s notice says
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 (PPPA), posing a risk of poisoning if the contents are swallowed by young children.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
What should you do?
Consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch in which to store the blister package medications. Consumers can continue to use the medication as directed. The child-resistant pouches should be used to store these medications until new child-resistant blister packaging is available.
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 or repair.
- How to reach the firm: Novartis toll-free at 866-629-6182 from 8 a.m. to 8 p.m. ET daily, email at Novartis5060@stericycle.com or online at www.pharma.us.novartis.com and in the top navigation of the page go to the News tab and click on Statements, or visit https://www.pharma.us.novartis.com/news/statements/corrective-action-certain-100-mg-sandimmune-and-neoral-blister-packages-us for more information.
Which ones are recalled?
This recall involves blister packages of prescription medications Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules from Novartis. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card and packages of Neoral 100 mg contain five blister cards with six soft gelatin capsules per card. The recalled blister packages have “Novartis,” the name of the medication, dosage, NDC, lot number and expiration date on the outer package and on the blister cards. Only 100 mg doses of these medications with the following NDC and lot numbers and expiration dates are included in this recall: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules 0078-0241-15 0078-0241-61 APCA136 APCA339 APCA793 APCC238 09/2020 02/2021 01/2022 07/2022 Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules 0078-0248-15 0078-0248-61 APCA437 APCA979 07/2020 03/2021
About 73,000 units, as CPSC gives them.
Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
CPSC’s photos
CPSC shows 2 photos on its notice. Hearth Record doesn’t copy them; each opens on cpsc.gov.
Who made and sold it?
- Distributed by Novartis Pharmaceuticals Corporation, East Hanover, N.J.
- Clinics and pharmacies nationwide as a prescribed medicine from March 2018 through March 2020, at prices varying based on quantities prescribed, health insurance terms, and other factors.
- Made in United States, as the notice gives it.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
Was anyone hurt?
None reported.
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.