Atorvastatin Calcium Tablets (Ascend) – Dissolution Failure (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ascend Laboratories LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Ascend Laboratories LLC is recalling Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0 due to Failed Dissolution Specifications. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specifications
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026