RecallRadar

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…

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

AgencyFDA Drug
Recall numberD-0301-2026
ClassificationClass II
Statusongoing
Initiated2026-01-21
Published2026-02-11
Last updated2026-09-13 11:52 UTC
CompanyUnichem Pharmaceuticals Usa
DistributionUS

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

ndc29300-187-13
ndc29300-187-01
ndc29300-187-05
ndc29300-187-10
ndc29300-188-13
ndc29300-188-01
ndc29300-188-05
ndc29300-188-10
ndc29300-189-13
ndc29300-189-01
ndc29300-189-05
ndc29300-189-10
code_infoLot # 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.

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.