FDA Drug recall D-0976-2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huah…

FDA Drug
Class II
ongoing
Published 2018-08-01

On 2018-08-01 the FDA classified a Class II recall of Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huah… by Prinston Pharmaceutical, citing CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0976-2018
Classification	Class II
Status	ongoing
Initiated	2018-07-13
Published	2018-08-01
Last updated	2026-09-13 11:52 UTC
Company	Prinston Pharmaceutical
Distribution	n/a

Product

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09

Reason

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Identifiers

ndc	43547-311-03
ndc	43547-311-09
ndc	43547-311-50
ndc	43547-312-03
ndc	43547-312-09
ndc	43547-312-50
ndc	43547-313-03
ndc	43547-313-09
ndc	43547-313-50
ndc	43547-314-03
ndc	43547-314-09
ndc	43547-314-50
ndc	43547-315-03
ndc	43547-315-09
ndc	43547-315-50
code_info	All lots within expiry.

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-0976-2018%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.