Clonidine Transdermal System recall
FDA recall D-0472-2026 · initiated Mar 19, 2026
Teva Pharmaceuticals USA, Inc recalled Clonidine Transdermal System in Mar 2026 — an FDA Class II recall (D-0472-2026) because CGMP Deviations: use of an unapproved raw material.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: use of an unapproved raw material
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 124,054 Cartons
Details
- Product
- Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Within U.S
- Initiated
- Mar 19, 2026
- FDA report date
- Apr 15, 2026
Frequently asked
- Was Clonidine Transdermal System recalled?
- Teva Pharmaceuticals USA, Inc recalled Clonidine Transdermal System in Mar 2026 — an FDA Class II recall (D-0472-2026) because CGMP Deviations: use of an unapproved raw material. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clonidine Transdermal System recalled?
- Per the FDA enforcement record, the reason for recall D-0472-2026 was: CGMP Deviations: use of an unapproved raw material
- Is a recalled Clonidine Transdermal System dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clonidine Transdermal System are affected?
- Distributed: Within U.S. The recall covers these lots — Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0472-2026.