Clonidine Hydrochloride Tablets — Class III drug recall D-1291-2020
Terminated recall by UNICHEM PHARMACEUTICALS USA INC, reported 2020-06-17, distributed nationwide. Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the p
| Recall number | D-1291-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | UNICHEM PHARMACEUTICALS USA INC, East Brunswick, NJ, United States |
| Recall initiated | 2020-05-26 |
| Classified | 2020-06-08 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2021-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 190,992 bottles |
| Reason classes | specification failure |
| NDC | 29300-0135, 29300-0135-01, 29300-0135-05, 29300-0135-10, 29300-0135-50, 29300-0136, 29300-0136-01, 29300-0136-05, 29300-0136-10, 29300-0136-50, 29300-0137, 29300-0137-01, 29300-0137-05, 29300-0137-10, 29300-0137-25, 29300-0468, 29300-0468-01, 29300-0468-05, 29300-0468-10, 29300-0468-50 |
| Lot numbers | GCLL19034, GCLL19035, GCLL19036, GCLL19044 |
| Expiration dates | 2021-04-30, 2021-06-30 |
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
Reason for recall
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1291-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.