Severity
Moderate
ModerateActive
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… - a moderate-severity action.
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 moderate-severity CPSC recall-The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PP….
- Moderate
- severity level
- 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 CPSC action (record #20091) was formally reported on March 18, 2020. It is classified under Moderate severity, with a current status of Active. Novartis Pharmaceuticals Corporation, of East Hanover, N.j. is listed as the recalling firm. Federal records list the affected scope as About 73,000.
The documented reason for this recall is: 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. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: 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 holding this product should act on that instruction 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
About 73,000
Related Recalls
6
0 from same agency
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 | Moderate |
| 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.
Frequently Asked Questions
What product was 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. Recalled by Novartis Pharmaceuticals Corporation, of East Hanover, N.j.. Units affected: About 73,000.
Why was this product recalled? ▼
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.
What should consumers 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.
Which agency issued this recall? ▼
This recall was issued by the CPSC on March 18, 2020. Severity: Moderate. Recall number: 20091.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (20091) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
How do I report an injury from a recalled product? ▼
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: CPSC, reported March 18, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.