RecallRadar

FDA Drug recall D-1107-2018

Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Su…

On 2018-08-29 the FDA classified a Class II recall of Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Su… by Preferred Pharmaceuticals, citing CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1107-2018
ClassificationClass II
Statusterminated
Initiated2018-08-15
Published2018-08-29
Last updated2026-09-13 11:52 UTC
CompanyPreferred Pharmaceuticals
DistributionAL

Product

Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9

Reason

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

Identifiers

code_infoLot # G2017F NDC 68788-6882-9

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-1107-2018%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.