Class II U.S. Food and Drug Administration

Teva Pharmaceuticals USA, Inc Clonidine Transdermal System, USP, 0.1 mg/day recall: CGMP Deviations: use of an unapproved raw material

Recall published 6 months ago

CGMP Deviations: use of an unapproved raw material

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: CGMP Deviations: use of an unapproved raw material

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0472-2026
Published
April 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Teva Pharmaceuticals USA, Inc
Product type
Prescription & OTC drugs
Units affected
124,054 Cartons
Made in
United States
Lot / code info
Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.

Products covered by this recall

Clonidine Transdermal System, USP, 0.1 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 0591-3508-04 carton, NDC 0591-3508-54 pouch

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 100060315

NDC number

On the carton and again on the bottle or blister label.

  • 0591-3508-04
  • 0591-3508-54

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.1 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Teva Pharmaceuticals USA, Inc — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  3. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  4. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Teva Pharmaceuticals USA, Inc — 400 Interpace Pkwy Bldg A, Parsippany, NJ, 07054-1120

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Teva Pharmaceuticals USA, Inc prescription & otc drugs recalled?

CGMP Deviations: use of an unapproved raw material CGMP Deviations: use of an unapproved raw material

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 100060315. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

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