FDA Drug recall D-1541-2022
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind
- FDA Drug
- Class III
- terminated
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class III recall of Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind by Unichem Pharmaceuticals Usa, citing product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1541-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-09-19 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
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
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
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 # GCLH22005, exp. date 02/29/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Unichem Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1541-2022%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.