RecallRadar

FDA Drug recall D-0222-2018

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc

On 2018-01-24 the FDA classified a Class II recall of Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc by Avkare, citing failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0222-2018
ClassificationClass II
Statusterminated
Initiated2018-01-03
Published2018-01-24
Last updated2026-09-13 11:52 UTC
CompanyAvkare
DistributionUS

Product

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

Reason

Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

Identifiers

code_infoLot: 15270, Exp. 01/18

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-0222-2018%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.