The Recall Desk
HighFDA (Drugs)·D-0018-2026·Announced 2025-10-22

Atorvastatin Calcium Tablets Recalled for Failed Dissolution Specifications

Ascend Laboratories is recalling specific lots of Atorvastatin Calcium Tablets 40 mg due to failed dissolution specifications. Affected lots are distributed nationwide in 90-count, 500-count, and 1000-count packages.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a quality defect in a prescription medication. Failed dissolution specifications present a risk-of-harm scenario in which patients may not receive proper medication dosing. No illnesses or injuries have been reported, consistent with a High (3) severity classification.

Plain-English summary

Ascend Laboratories, LLC is recalling certain lots of Atorvastatin Calcium Tablets USP, 40 mg, due to failed dissolution specifications. The medication is a prescription statin distributed nationwide in the United States.

The recall affects the following lot numbers: 25140933 (expires Feb. 2027), 25140477 (expires Dec. 2026), 24144254 (expires Oct. 2026), 24144163 (expires Sep. 2026), and 24143995 (expires Sep. 2026). The affected product is available in three package sizes: 90-count (NDC 67877-513-90), 500-count (NDC 67877-513-05), and 1000-count (NDC 67877-513-10).

Consumers who have purchased affected lots should contact their pharmacist or healthcare provider with any questions about their medication. Patients should not discontinue use of their medication without consulting their healthcare provider.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Ascend Laboratories, LLC
Category
Drug — Prescription Statin
Hazard
  • failed-dissolution

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot#: 25140933
  • Exp. Feb. 2027 Lot#: 25140477
  • Exp. Dec. 2026 Lot#: 24144254
  • Exp. Oct. 2026 Lot#: 24144163
  • Exp. Sep. 2026 Lot#: 24143995
  • Exp. Sep. 2026

UPCs (3)

  • 0367877512051
  • 0367877513102
  • 0367877514109

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ATORVASTATIN CALCIUM

Same category