Recall of Clonidine Transdermal System Due to Manufacturing Issue
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Teva Pharmaceuticals USA, Inc. is recalling 124,054 cartons of Clonidine Transdermal System because of CGMP deviations involving an unapproved raw material.
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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
The recall was initiated due to CGMP deviations, specifically the use of an unapproved raw material in the production of the drug.
Which Products Are Affected
The affected product is Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers. It includes NDC codes such as 0591-3508-04, 0591-3508-54, 0591-3509-04, 0591-3509-54, 0591-3510-04, and 0591-3510-54. The recall involves lots 100060315 (expiration 04/2026) and 100068644 (expiration 01/2027), with a total of 124,054 cartons distributed within the United States.
What You Should Do
Consumers who have the affected product should contact Teva Pharmaceuticals USA, Inc., as the recall was initiated via letter, for instructions on returns or refunds.
Why This Matters
This recall affects a prescription drug used for medical treatment, potentially impacting patients who rely on it and highlighting the importance of manufacturing standards in pharmaceuticals.
Source
This information is from the FDA recall notice, recall number D-0472-2026.
Original source: FDA Official Notice ↗
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