FDA Drug recall D-0301-2026
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS L…
- FDA Drug
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS L… by Unichem Pharmaceuticals Usa, citing cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0301-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-21 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
Product
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Reason
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Identifiers
| ndc | 29300-187-13 |
|---|---|
| ndc | 29300-187-01 |
| ndc | 29300-187-05 |
| ndc | 29300-187-10 |
| ndc | 29300-188-13 |
| ndc | 29300-188-01 |
| ndc | 29300-188-05 |
| ndc | 29300-188-10 |
| ndc | 29300-189-13 |
| ndc | 29300-189-01 |
| ndc | 29300-189-05 |
| ndc | 29300-189-10 |
| code_info | Lot # GBHL24005A, Exp Date: 09/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class I · 2025-09-24 · Unichem Pharmaceuticals Usa - Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind
FDA Drug · Class III · 2022-09-28 · Unichem Pharmaceuticals Usa - Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind
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All Unichem Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0301-2026%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.