Why it was recalled
CGMP Deviations: use of an unapproved raw material
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Where it was sold
Within U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0474-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 19, 2026
- FDA report date
- Apr 15, 2026
- Quantity
- 113,943 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0474-2026, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98614
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
- Postal code
- 07054-1120
- Report date
- Apr 15, 2026
- Product type
- Drugs
- Recall number
- D-0474-2026
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 113,943 Cartons
- Reason for recall
- CGMP Deviations: use of an unapproved raw material
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Within U.S
- Recall initiation date
- Mar 19, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2026