FDA Drug recall D-0829-2020
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd
- FDA Drug
- Class III
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class III recall of Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd by Unichem Pharmaceuticals Usa, citing 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 co….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0829-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-01-29 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
Product
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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
Reason
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.
Identifiers
| ndc | 29300-468-05 |
|---|---|
| ndc | 29300-468-10 |
| ndc | 29300-468-50 |
| ndc | 29300-468-01 |
| ndc | 29300-136-01 |
| ndc | 29300-136-05 |
| ndc | 29300-136-10 |
| ndc | 29300-136-50 |
| ndc | 29300-137-01 |
| ndc | 29300-137-05 |
| ndc | 29300-137-10 |
| ndc | 29300-137-25 |
| ndc | 29300-135-01 |
| ndc | 29300-135-05 |
| ndc | 29300-135-10 |
| ndc | 29300-135-50 |
| code_info | Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0829-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.