The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0017-2026·Announced 2025-10-22

Atorvastatin 10 mg tablets recalled after failing dissolution specifications

Ascend Laboratories is recalling 141,984 bottles of Atorvastatin Calcium Tablets USP 10 mg for failed dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: Scored 2 as a specification failure: the record states only that dissolution specifications were not met, without describing a health consequence or reporting injury.

Plain-English summary

Atorvastatin Calcium Tablets, USP, 10 mg, in 90-count, 500-count and 1000-count bottles, manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories, are being recalled for failed dissolution specifications.

The recall covers 141,984 bottles from lots including 25141249 (expiring February 2027), 24144938, 24144868 and 24144867 (expiring November 2026), carrying NDCs 67877-511-90, 67877-511-05 and 67877-511-10. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.

The enforcement record states the dissolution failure without describing a health consequence, and reports no injuries.

Atorvastatin is a prescription medicine taken daily, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Ascend Laboratories, LLC
Category
Drug — Statin
Hazard
Affected units
141,984

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 (9)

  • Lot#: 25141249
  • Exp. Feb. 2027 Lot#: 24144938
  • Exp. Nov. 2026 Lot#: 24144868
  • Exp. Nov. 2026 Lot#: 24144867
  • Exp. Nov. 2026 Lot#: 24144458
  • Exp. Sep. 2026 Lot#: 24143994
  • Exp. Sep. 2026 Lot#: 24142987
  • Exp. July 2026 Lot#: 24143316
  • Exp. July 2026

UPCs (3)

  • 0367877512051
  • 0367877513102
  • 0367877514109

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Ascend Laboratories, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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