RecallRadar

FDA Drug recall D-0416-2018

Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only

On 2018-02-21 the FDA classified a Class III recall of Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only by Genentech, citing labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0416-2018
ClassificationClass III
Statusterminated
Initiated2018-02-05
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanyGenentech
DistributionUS

Product

Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01

Reason

Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

Identifiers

code_infoLot # 3141989, EXP 08/31/2019

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-0416-2018%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.