Clonidine Hydrochloride Tablets — Class III drug recall D-1541-2022
Terminated recall by UNICHEM PHARMACEUTICALS USA INC, reported 2022-09-28, distributed nationwide. Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength C
| Recall number | D-1541-2022 |
|---|---|
| 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 | 2022-09-19 |
| Classified | 2022-09-22 |
| Reported by FDA | 2022-09-28 |
| Terminated | 2023-03-02 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| 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 | GCLH22005 |
| Expiration dates | 2024-02-29 |
Product
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, 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# 29300-137-01
Reason for recall
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
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-1541-2022. 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.