The Recall Desk
ModerateFDA (Drugs)·D-0020-2026·Announced 2025-10-22

Atorvastatin Calcium Tablets Recalled for Failed Dissolution Specifications

Ascend Laboratories is recalling specific lots of Atorvastatin Calcium 80 mg tablets distributed nationwide because the tablets failed to meet dissolution specifications, a manufacturing quality issue.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard (failed dissolution specifications) represents a pharmaceutical quality defect that could affect medication efficacy, but poses no immediate safety threat.

Plain-English summary

Ascend Laboratories, LLC is recalling ten specific lots of Atorvastatin Calcium Tablets USP, 80 mg, a prescription medication. The affected tablets were manufactured by Alkem Laboratories, Ltd. in India and distributed nationwide in the United States.

The tablets are being recalled because they failed to meet dissolution specifications. This manufacturing quality issue means the tablets may not break down and release the active medication as intended in the digestive system.

The recall affects the following lot numbers, all with expiration dates between August 2026 and December 2026: Lot 25140249 (Dec 2026), Lot 25140247 (Dec 2026), Lot 24144999 (Nov 2026), Lot 24144942 (Nov 2026), Lot 24144845 (Nov 2026), Lot 24144713 (Nov 2026), Lot 24144652 (Oct 2026), Lot 24143898 (Aug 2026), Lot 24143412 (Aug 2026), and Lot 24143582 (Aug 2026).

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Ascend Laboratories, LLC
Category
Drug
Hazard
  • failed-dissolution
  • quality-defect

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 (11)

  • Lot#: 25140249
  • Exp. Dec. 2026 Lot#: 25140247
  • Exp. Dec. 2026 Lot#: 24144999
  • Exp. Nov. 2026 Lot#: 24144942
  • Exp. Nov. 2026 Lot#: 24144845
  • Exp. Nov. 2026 Lot#: 24144713
  • Exp. Nov. 2026 Lot#: 24144652
  • Exp. Oct. 2026 Lot#: 24143898
  • Exp. Aug. 2026 Lot#: 24143412
  • Exp. Aug. 2026 Lot#: 24143582
  • Exp. Aug. 2026

UPCs (3)

  • 0367877512051
  • 0367877513102
  • 0367877514109

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ATORVASTATIN CALCIUM

Same category