Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
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📍Recalling firmUNICHEM PHARMACEUTICALS USA INC1 Tower Center Blvd Ste 2200 · East Brunswick, NJ 08816-1145
✎ GovInfoNow plain-language explainer
Unichem Pharmaceuticals USA Inc. is recalling Clonidine Hydrochloride Tablets, USP 0.1mg because of potential migration of Benzophenone into the product from the container label. The recall affects approximately 19,161,600 units distributed nationwide in the US. This is a Class III recall initiated as a precautionary measure. Read more at govinfonow.com/recall/37391-unichem-recalls-clonidine-tablets-due-to-impurity-risk.
“Unichem Recalls Clonidine Tablets Due to Impurity Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37391-unichem-recalls-clonidine-tablets-due-to-impurity-risk. Based on FDA recall #D-0829-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0829-2020%22&limit=1).
The FDA announced on Jan. 29, 2020, that Unichem Pharmaceuticals USA Inc. voluntarily recalled Clonidine Hydrochloride Tablets due to potential migration of Benzophenone from container labels. The agency classified the Class III recall as a precautionary measure against failed impurity specifications.
The recall addresses potential migration of Benzophenone at very low levels into the product from the container label. GovInfoNow's records show this is a Class III recall initiated as a precautionary measure due to failed impurity specifications.
Context
GovInfoNow's records show Unichem Pharmaceuticals USA Inc. has 11 other recalls on record since July 30, 2015. Recent brand recalls include busPIRone 5mg Tablets recalled on April 13, 2026, for subpotent drug risk; Doxazosin 4mg Tablets recalled on Jan. 21, 2026, due to wrong ID imprint; and Bisoprolol/Hydrochlorothiazide Tablets recalled on Jan. 21, 2026, for N-Nitroso impurity risk. Other recent recalls of similar products include Teva Clonidine Transdermal System recalled on March 19, 2026, for unapproved raw material risk; Baxter Clindamycin Injection recalled on Aug. 6, 2026, for CGMP deviations; and Alembic Fesoterodine Tablets recalled on Dec. 16, 2025, for diester impurity risk.
How to tell if you have this one
Check for Clonidine Hydrochloride Tablets, USP 0.1mg in 100-count bottles manufactured by Unichem Laboratories Ltd. Look for NDC 29300-135-01 and the following lot numbers: GCLL18108 (EXP 10/31/2020), GCLL18109 (EXP 10/31/2020), GCLL18110 (EXP 10/31/2020), and GCLL19003 (EXP 12/31/2020).
Brand
Unichem Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC, lot numbers, and expiration dates listed in the recall record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for your specific prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0829-2020 (January 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0829-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.