The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0019-2026·Announced 2025-10-22

Atorvastatin 20 mg tablets recalled after failing dissolution specifications

Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 20 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, 20 mg, in 90-count, 500-count and 1000-count bottles, manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories of Parsippany, New Jersey, are being recalled for failed dissolution specifications.

The recall covers lots including 25140150, 25140173 and 25140172, all expiring December 2026, carrying NDCs 67877-512-90, 67877-512-05 and 67877-512-10. 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

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 (12)

  • Lot #: 25140150
  • Exp. Dec. 2026 Lot #: 25140173
  • Exp. Dec. 2026 Lot #: 25140172
  • Exp. Dec. 2026 Lot #: 24144720
  • Exp. Nov. 2026 Lot #: 24144798
  • Exp. Nov. 2026 Lot #: 24144692
  • Exp. Oct. 2026 Lot #: 24143755
  • Exp. Aug. 2026 Lot #: 24143913
  • Exp. Aug. 2026 Lot #: 24143754
  • Exp. Aug. 2026 Lot #: 24143047
  • Exp. June 2026 Lot #: 24142936
  • 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 →

Related recalls

Same brand · ATORVASTATIN CALCIUM

Same manufacturer · Ascend Laboratories, LLC

See all →

Same hazard · failed dissolution

See all →

Similar recalls