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Unrated Drug recall · FDA · Published March 19, 2026

Teva Clonidine Transdermal System Recall: Unapproved Raw Material Risk

Teva recalls Clonidine Transdermal System due to use of unapproved raw material. Affected units have specific NDC numbers and expiration dates. Consumers should contact Teva for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0473-2026DrugTeva ›
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Contact the company

Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer

Teva is recalling Clon: 0.2 mg/day transdermal patches because they used an unapproved raw material during manufacturing. This could lead to unsafe drug content in the product. Read more at govinfonow.com/recall/31416-teva-clonidine-transdermal-system-recall-unapproved-raw-material-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31416-teva-clonidine-transdermal-system-recall-unapproved-raw-material-risk · Updated August 7, 2026 · FDA enforcement record: FDA #D-0473-2026

Cite this page

“Teva Clonidine Transdermal System Recall: Unapproved Raw Material Risk.” GovInfoNow, updated August 7, 2026. https://govinfonow.com/recall/31416-teva-clonidine-transdermal-system-recall-unapproved-raw-material-risk. Based on FDA recall #D-0473-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0473-2026%22&limit=1).

The FDA announced on March 19, 2026, that Teva Pharmaceuticals USA, Inc. is recalling Clonidine Transdermal System, USP, 0.2 mg/day due to current good manufacturing practice deviations involving an unapproved raw material. The recall affects 62,136 cartons distributed within the U.S.

How to tell if you have it

  • Brand: Teva
  • Product: Clonidine Transdermal System, USP, 0.2 mg/day
  • NDC: 0591-3509-04 (carton), 0591-3509-54 (pouch)
  • Lot codes: 100060002 (Exp. 07/2026), 100066802 (Exp. 05/2027)

The hazard

The recall is due to CGMP deviations specifically the use of an unapproved raw material in the manufacturing process. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Nivagen Zinc Oxide Ointment Recall: C G M P Deviations (2025-10-31) and Blossom Pharmaceuticals Zinc Oxide Ointment Recall: Cgmp Deviations (2025-10-31).

How to tell if you have this one

Check for NDC numbers 0591-3509-04 (carton) or 0591-3509-54 (pouch). Products with lot numbers 100060002 (expiring 07/2026) or 100066802 (expiring 05/2027) are affected.

  • Brand
    Teva
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Within U.S
  • NDC
    0591-3508-54, 0591-3508-04, 0591-3509-54, 0591-3509-04, 0591-3510-54, 0591-3510-04
Recall numberProduct, codes & lotsQuantity
D-0472-2026Clonidine 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; Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.124,054 Cartons
D-0473-2026Clonidine Transdermal System, USP, 0.2 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 0591-3509-04 carton, NDC 0591-3509-54 pouch; Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/202762,136 Cartons
D-0474-2026Clonidine 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: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.113,943 Cartons
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC numbers 0591-3509-04 or 0591-3509-54 and lot numbers 100060002 or 100066802.

How this recall unfolded

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Mar 19, 202612. FDA classified it Class II: Apr 13, 202623. Published in FDA’s Enforcement Report: Apr 15, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Other Teva recalls

Teva Pharmaceuticals USA, Inc recalls traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o,
August 24, 2026Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing:
April 24, 2026Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister
April 6, 2026Teva Pharmaceuticals USA, Inc recalls Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles
January 29, 2026Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA,
January 12, 2026Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by:
November 7, 2025

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0473-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0473-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA