HIGH

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India,...

Failed Dissolution Specifications

Quick Facts at a Glance

Recall Date
September 19, 2025
Hazard Level
HIGH
Brands
ATORVASTATIN CALCIUM, Ascend Laboratories, LLC
Geographic Scope
1 states

Hazard Information

Failed Dissolution Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter

Full Description

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.. Generic: ATORVASTATIN CALCIUM; Brand: ATORVASTATIN CALCIUM. Reason: Failed Dissolution Specifications. Classification: Class II. Distribution: U.S. Nationwide

View Original Recall on FDA - Drug Safety

Want Alerts Like This?

Get notified about recalls in categories you care about.

Product Classification

Product Details

Model Numbers
Lot #: 25140150
Exp. Dec. 2026 Lot #: 25140173
Exp. Dec. 2026 Lot #: 25140172
Exp. Dec. 2026 Lot #: 24144720
Exp. Nov. 2026 Lot #: 24144798
+7 more
UPC Codes
67877-511
67877-512
67877-513
+11 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more