CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report
Clonidine Transdermal System, USP, 3 mg/day, supplied recalled
Teva Pharmaceuticals USA is recalling Clonidine Transdermal System, USP, 3 mg/day, supplied in cartons of 4 Systems and 4. The recall was initiated on 19 Mar 2026 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-0474-2026
- FDA event ID
- 98614
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2026
- FDA classified
- 13 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 19 Mar 2026 | Recall initiated by company | |
| 13 Apr 2026 | Classified by FDA | +25 days |
| 15 Apr 2026 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: use of an unapproved raw material
Product as listed by the FDA
Clonidine Transdermal System, USP, 0.3 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 0591-3510-04 carton, NDC 0591-3510-54 pouch
Where it was distributed
Within U.S
Questions about this recall
Is Clonidine Transdermal System, USP, 3 mg/day, supplied in cartons of 4 Systems and 4 recalled?
Yes. Teva Pharmaceuticals USA recalled Clonidine Transdermal System, USP, 3 mg/day, supplied in cartons of 4 Systems and 4 on 19 Mar 2026. The recall is Class II and its status is Ongoing. Recall number D-0474-2026.
Why was it recalled?
CGMP Deviations: use of an unapproved raw material
Which lots are affected?
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Where was it sold?
Within U.S
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Clonidine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine Transdermal System, USP, 1 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 2 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Clonidine Transdermal System, USP 3 mg/day, 4 Patches recalledClonidine | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Clonidine Hydrochloride Tablets, USP, 1 mg recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |