CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report

Atorvastatin Calcium Tablet USP 80 mg, a) recalled

Ascend Laboratories is recalling Atorvastatin Calcium Tablet USP 80 mg, a) (, distributed nationwide in the US. The recall was initiated on 19 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021
Quantity recalleda) 5,472 bottles and b) 5,880 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1515-2019
FDA event ID
83378
Recalling firm
Ascend Laboratories, Parsippany, NJ
Classification
Class II
Status
Terminated
Recall initiated
19 Jul 2019
FDA classified
24 Jul 2019
Reported
31 Jul 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

19 Jul 2019Recall initiated by company
24 Jul 2019Classified by FDA+5 days
31 Jul 2019Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ

Where it was distributed

Product was shipped to wholesalers throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

a) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021

Where was it sold?

Product was shipped to wholesalers throughout the United States.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Atorvastatin recalls

All 48
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAtorvastatin Calcium Tablets USP, 40 mg recalled by Ascend LaboratoriesAtorvastatin CalciumAscend LaboratoriesPotency & AssayNationwide
DrugCLASS IIAtorvastatin Calcium Tablets USP, 10 mg recalled by Ascend LaboratoriesAtorvastatin CalciumAscend LaboratoriesPotency & AssayNationwide
DrugCLASS IIAtorvastatin Calcium Tablets USP, 20 mg recalled by Ascend LaboratoriesAtorvastatin CalciumAscend LaboratoriesPotency & AssayNationwide
DrugCLASS IIAtorvastatin Calcium Tablets USP, 80 mg recalled by Ascend LaboratoriesAtorvastatin CalciumAscend LaboratoriesPotency & AssayNationwide
DrugCLASS IIAtorvastatin Calcium Tablets USP 40 mg recalled by Biocon PharmaAtorvastatin CalciumBiocon PharmaPotency & AssayNationwide