FDA Drug recall D-0209-2018

Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zheji…

FDA Drug
Class II
terminated
Published 2018-01-17

On 2018-01-17 the FDA classified a Class II recall of Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zheji… by Prinston Pharmaceutical, citing failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0209-2018
Classification	Class II
Status	terminated
Initiated	2017-11-29
Published	2018-01-17
Last updated	2026-09-13 11:52 UTC
Company	Prinston Pharmaceutical
Distribution	US

Product

Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.

Reason

Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

Identifiers

ndc	43547-367-03
ndc	43547-367-09
ndc	43547-367-50
ndc	43547-367-11
ndc	43547-368-03
ndc	43547-368-09
ndc	43547-368-50
ndc	43547-368-11
ndc	43547-369-03
ndc	43547-369-09
ndc	43547-369-50
ndc	43547-369-11
ndc	43547-370-03
ndc	43547-370-09
ndc	43547-370-50
ndc	43547-370-11
code_info	Lot #: 343B17025, Exp 03/31/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0209-2018%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.