RecallRadar

FDA Drug recall D-0595-2018

Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11

On 2018-02-21 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11 by American Health Packaging, citing CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0595-2018
ClassificationClass II
Statusterminated
Initiated2018-01-19
Published2018-02-21
Last updated2026-09-13 11:52 UTC
CompanyAmerican Health Packaging
DistributionUS

Product

Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

Reason

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Identifiers

ndc60687-157-11
ndc60687-157-21
ndc60687-157-94
ndc60687-168-11
ndc60687-168-01
ndc60687-168-65
ndc60687-179-11
ndc60687-179-01
ndc60687-179-65
ndc60687-191-11
ndc60687-191-21
ndc60687-191-94
ndc60687-202-11
ndc60687-202-21
ndc60687-202-94
ndc60687-213-11
ndc60687-213-21
ndc60687-213-94
code_infoLot #: 174096, Exp 05/31/19

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-0595-2018%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.