CLASS II ONGOING Drug recall · Reported 3 Sep 2025 · FDA Enforcement Report
H-e-b, inControl, Sterile* Alcohol Pads, Cont recalled
Medline Industries LP - Northfield is recalling H-e-b, inControl, Sterile* Alcohol Pads, Cont, distributed nationwide in the US. The recall was initiated on 7 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0603-2025
- FDA event ID
- 97385
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Brand
- Incontrol Alcohol
- Manufacturer
- H-E-B
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jul 2025
- FDA classified
- 26 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Jul 2025 | Recall initiated by company | |
| 26 Aug 2025 | Classified by FDA | +50 days |
| 3 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Where it was distributed
Nationwide
Stores named: H-E-B
Questions about this recall
Why was it recalled?
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Which lots are affected?
61224080041
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97385This product is part of a recall event; the main page for the event is Good Neighbor Pharmacy, Alcohol Prep Pads recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Good Neighbor Pharmacy, Alcohol Prep Pads recalledGood Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser | Medline Industries LP - Northfield | Potency & Assay | Nationwide | |
| CLASS II | Curad Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents recalledCurad Alcohol Prep Pads | Medline Industries LP - Northfield | Potency & Assay | Nationwide | |
| CLASS II | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs recalledWalmart | Medline Industries LP - Northfield | Potency & Assay | Nationwide | |
| CLASS II | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol recalledMedline Alcohol Prep | Medline Industries LP - Northfield | Potency & Assay | Nationwide | |
| CLASS II | Rite Aid Pharmacy, first aid alcohol prep pads recalledAlcohol | Medline Industries LP - Northfield | Potency & Assay | Nationwide |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Isopropyl Alcohol recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%) recalledFirst Aid Only Hand Sanitizing Wipe | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rite Aid Pharmacy, first aid alcohol prep pads recalledAlcohol | Medline Industries LP - Northfield | Potency & Assay | Nationwide |
| Drug | CLASS II | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol recalledMedline Alcohol Prep | Medline Industries LP - Northfield | Potency & Assay | Nationwide |
| Drug | CLASS II | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs recalledWalmart | Medline Industries LP - Northfield | Potency & Assay | Nationwide |
| Drug | CLASS II | Curad Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents recalledCurad Alcohol Prep Pads | Medline Industries LP - Northfield | Potency & Assay | Nationwide |