Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
TopCare Health 70% Isopropyl Alcohol (Isopropyl Rubbing Alcohol)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross Contamination with Other Products.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
Affected NDC
36800-0589-14
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
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 |
|---|---|---|---|---|
| 70% Isopropyl Rubbing Alcohol Isopropyl Rubbing Alcohol NDC 36800-0589 |
ISOPROPYL ALCOHOL 70 mL/100mL | Solution Topical |
Topco Associates LLC | OTC |
- Recalling firm
- Consumer Product Partners, LLC
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0661-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Alcohol recalls
See all
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
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other recalls by Consumer Product Partners, LLC
All 2025 recalls
Class III · Low risk
Kroger 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class II · Moderate risk
Spectrum Advanced Gel Hand Sanitizer
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Class II · Moderate risk
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Class II · Moderate risk
Petroleum Jelly
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
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