Unichem Pharmaceuticals USA recalls 0.1 mg clonidine tablets due to potential benzophenone migration from containers. These prescription-only tablets were manufactured in India and distributed in the US. Consumers should contact the company for details.
“Unichem Clonidine Tablets Recall: Potential Benzophenone Migration Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37100-unichem-clonidine-tablets-recall-potential-benzophenone-migration-risk. Based on FDA recall #D-1291-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1291-2020%22&limit=1).
The FDA announced on May 26, 2020, that Unichem Pharmaceuticals USA Inc. voluntarily recalled Clonidine Hydrochloride Tablets USP 0.1 mg due to potential benzophenone migration from the container. The recall affects 190,992 bottles distributed nationwide.
According to the FDA, the product failed impurities and degradation specifications due to the potential migration of benzophenone at a very low level into the product from the container.
Context
GovInfoNow's records show Unichem Pharmaceuticals USA Inc. has 11 other recalls on record since July 30, 2015. Other recent recalls of similar products include Unichem busPIRone 5mg Tablets Recall (April 13, 2026) and Unichem Recalls Doxazosin 4mg Tablets Due to Wrong ID Imprint (Jan. 21, 2026). Other recent recalls of similar products include Teva Clonidine Transdermal System Recall (March 19, 2026) and Bionpharma Divalproex Tablets Recall (June 26, 2026).
How to tell if you have this one
Check for the product name 'Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles' with NDC 29300-135-01. The lot numbers GCLL19034, GCLL19035, GCLL19036 (expiring 4/30/2021) and GCLL19044 (expiring 6/30/2021) are affected.
Brand
Unichem Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 29300-135-01 and lot numbers GCLL19034, GCLL19035, GCLL19036 (expiring 4/30/2021) or GCLL19044 (expiring 6/30/2021) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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-1291-2020 (May 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1291-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.