RecallRadar

FDA Drug recall D-0824-2018

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

On 2018-05-30 the FDA classified a Class II recall of Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 by Mylan Pharmaceuticals, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0824-2018
ClassificationClass II
Statusterminated
Initiated2018-04-24
Published2018-05-30
Last updated2026-09-13 11:52 UTC
CompanyMylan Pharmaceuticals
DistributionUS

Product

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

Reason

CGMP Deviations

Identifiers

code_info
NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp.…NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19

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-0824-2018%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.