CPSC recall · Reported March 18, 2020
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
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…
Novartis Pharmaceuticals Corporation, of East Hanover, N.j. recalled This recall involves blister packages of prescription medications Sandimmune® (cyclospori….
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to F… was recalled by Novartis Pharmaceuticals Corporation, of East Hanover, N.j. in March 18, 2020. Reason: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PP…. Remedy: Consumers should immediately secure the product out of the sight and reach of children an…. Verify recall #20091 with the CPSC before acting.
The recall
Novartis Pharmaceuticals Corporation, of East Hanover, N.j. issued this CPSC recall-The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PP….
- None
- agency class
- March 18, 2020
- reported
Sourced from official CPSC enforcement records. Verify recall #20091 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. Consumers holding this product should act on the agency's documented remedy above rather than relying on general guidance.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Product description
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
Reason for recall
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.
Remedy, what to 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Consumer Product Safety Commission |
| Severity class | Not classified by agency |
| Status | Active |
| Recall number | 20091 |
| Date reported | March 18, 2020 |
| Date initiated | March 18, 2020 |
| Recalling firm | Novartis Pharmaceuticals Corporation, of East Hanover, N.j. |
| Affected scope | About 73,000 |
| Distribution | Not disclosed |
| Official source | CPSC notice → |
Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.
What to do with this recall
Consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free chi…
- Check the recall number (20091) and product description against the item you own. Search the archive
- Confirm the current status and remedy on the official CPSC notice before acting. CPSC notice
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official CPSC record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
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Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026