Teva clonidine transdermal patches recalled over unapproved raw material use
Teva is recalling two lots of Clonidine Transdermal System, USP, 0.1 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 124,054 cartons are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall arising from a manufacturing compliance deviation with no product-quality or health consequence described in the source, which places it at the precautionary Moderate level.
Plain-English summary
Teva Pharmaceuticals USA, Inc is recalling Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of four systems and four adhesive covers. The carton NDC is 0591-3508-04 and the pouch NDC is 0591-3508-54. The action covers 124,054 cartons.
The stated reason is current good manufacturing practice deviations, specifically the use of an unapproved raw material. The FDA classified the action as Class II. The source does not describe any resulting effect on the potency, purity or performance of the patches.
Affected lots are 100060315 (exp 04/2026) and 100068644 (exp 01/2027). Distribution was within the United States.
This is a prescription product. Patients should not stop using a prescribed medicine without advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
- Brand
- CLONIDINE TRANSDERMAL SYSTEM
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Transdermal patch
- Affected units
- 124,054
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: 100060315
- Exp.: 04/2026
- 100068644
- Exp.: 01/2027.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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- ModerateClonidine Transdermal System patches recalled for impurities and degradation
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