Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Simethicone 20 mg per 0.3 mL Oral Syringe
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Affected NDC
0536-1303-75
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Infants Simethicone NDC 00536-1303 |
DIMETHICONE, UNSPECIFIED 20 mg/.3mL | Suspension/ Drops Oral |
Rugby Laboratories | OTC |
- Recalling firm
- Safecor Health, LLC
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0251-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Safecor Health, LLC
All 2025 recalls
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other packaging defect recalls from 2025
All packaging defect recalls
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Carton label: Testosterone Gel 1%
Defective Container - A defect in the side-seal which allows leakage of product.
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
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