Clonidine Transdermal System Recall Over Manufacturing Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Teva Pharmaceuticals USA, Inc. is recalling 62,136 cartons of Clonidine Transdermal System due to CGMP deviations involving the use of an unapproved raw material, affecting products distributed within the U.S.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
Clonidine Transdermal System Recall
What Happened
Teva Pharmaceuticals USA, Inc. is initiating a voluntary recall of Clonidine Transdermal System because of CGMP deviations, specifically the use of an unapproved raw material in the manufacturing process.
Which Products Are Affected
The affected product is Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers. It is identified by NDC codes such as 0591-3509-04 and 0591-3509-54, with lot numbers 100060002 (expiration 07/2026) and 100066802 (expiration 05/2027). A total of 62,136 cartons are involved, and the products were distributed within the U.S.
What You Should Do
Consumers who have the affected product should follow the initial firm notification, which was issued via letter, and contact Teva Pharmaceuticals USA, Inc. at their address: 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054-1120, for instructions on returns or refunds related to recall number D-0473-2026.
Why This Matters
This recall highlights potential quality issues in prescription drugs, affecting over 62,000 cartons distributed in the United States and emphasizing the importance of adhering to manufacturing standards to ensure product safety.
Source
FDA recall notice for event ID 98614, available through the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,326 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.