Unichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration
Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from containers.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Unichem Pharmaceuticals (USA), Inc. is recalling specific lots of Clonidine Hydrochloride Tablets, USP 0.1 mg, 100-count bottles. The recall involves 190,992 bottles distributed nationwide within the United States. The affected lots are GCLL19034, GCLL19035, GCLL19036 (Exp. 4/30/2021) and GCLL19044 (Exp. 6/30/2021).
The recall was initiated because of failed impurities/degradation specifications. Specifically, there is a potential for benzophenone to migrate at very low levels into the product from the container. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on replacement or alternative treatment. The product is prescription-only.
The recalled product
- Product
- CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
- Brand
- CLONIDINE HYDROCHLORIDE
- Manufacturer
- UNICHEM PHARMACEUTICALS USA INC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 190,992
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: GCLL19034
- GCLL19035
- GCLL19036
- Exp. 4/30/2021
- GCLL19044
- Exp. 6/30/2021
UPCs (4)
- 0329300137019
- 0329300136012
- 0329300135015
- 0329300468014
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CLONIDINE HYDROCHLORIDE
- ModerateClonidine Hydrochloride 0.3 mg Tablets Recalled for Strength Mix-up
FDA (Drugs) · 2022-09-28
- LowUnichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration
FDA (Drugs) · 2020-02-12
Same manufacturer · UNICHEM PHARMACEUTICALS USA INC
See all →- LowBuspirone Hydrochloride Tablets 5 mg Recalled for Subpotency
FDA (Drugs) · 2026-05-13
- ModerateDoxazosin tablets recalled after being imprinted with the wrong identifier
FDA (Drugs) · 2026-02-18
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- CriticalCyclobenzaprine bottles recalled after being filled with meloxicam tablets instead
FDA (Drugs) · 2025-09-24
- LowTopiramate 50 mg tablets recalled due to discoloration
FDA (Drugs) · 2021-12-01
Similar recalls
- LowUnichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration
FDA (Drugs) · 2020-02-12
- ModerateClonidine Hydrochloride 0.3 mg Tablets Recalled for Strength Mix-up
FDA (Drugs) · 2022-09-28
- HighUnichem Recalls Hydrochlorothiazide Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2015-09-02
- ModerateMutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
FDA (Drugs) · 2015-08-05
- LowBuspirone Hydrochloride Tablets 5 mg Recalled for Subpotency
FDA (Drugs) · 2026-05-13
- HighUnichem Recalls Divalproex Sodium Tablets Due to Metronidazole Contamination
FDA (Drugs) · 2018-01-24