Clonidine Hydrochloride Tablets (Unichem) – Benzophenone Migration (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01
Brand
UNICHEM PHARMACEUTICALS USA INC
Lot Codes / Batch Numbers
Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021, GCLL19044, Exp. 6/30/2021
Products Sold
Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
UNICHEM PHARMACEUTICALS USA INC is recalling Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Lab due to Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026