Lower riskMedical device recall · FDA · Published November 10, 2021
Tapemark iontoPATCH Extra Strength Patch Recall: Incorrect Dosage Label
Tapemark recalls extra strength iontoPATCH patches due to incorrect dosage information on pouches. The primary carton label is correct. Consumers should check lot numbers 1131-1 and :1131-2.
“Tapemark iontoPATCH Extra Strength Patch Recall: Incorrect Dosage Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61552-tapemark-iontopatch-extra-strength-patch-recall-incorrect-dosage-label. Based on FDA recall #Z-0454-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0454-2022%22&limit=1).
The FDA announced on 2021-11-10 that Tapemark Company voluntarily recalled iontoPATCH On-the-Go Patch Therapy due to incorrect dosage information on the pouch. The primary carton label is correct. Owners should contact the company for a refund.
How to tell if you have it
Brand: Tapemark
Product: iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time
Lot numbers: 1131-1 and 1131-2
Quantity: 5,141 primary cartons
The hazard
The dosage information on the pouch is incorrect, although the primary carton label is correct. The FDA has classified this as a Class III recall.
Context
GovInfoNow's records show other recent recalls of similar products include Broselow Pediatric Emergency Rainbow Tape Recall: Dosing Errors for Critical Medicines (2025-12-15) and Omnicell i.v.Station Label Stock Recall: Risk of Mislabeled Syringes (2026-03-25).
How to tell if you have this one
Check for lot numbers 1131-1 or 1131-2 on the pouches. The product is an extra strength iontoPATCH patch with 8-hour average wear time.
Brand
Tapemark
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Pouch Lot Number
Look for lot numbers 1131-1 or 1131-2 on the pouches.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Missouri, New York, Ohio, Tennessee.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0454-2022 (November 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0454-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.