Atorvastatin Calcium Tablets Recalled Due to Failed Dissolution Specifications
Ascend Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide due to failed dissolution specifications. The 141,984 affected bottles across three package sizes may not release medication properly for patient absorption.
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 hospitalizations, illnesses, or injuries. The hazard is a quality specification failure affecting medication dissolution and bioavailability rather than an acute safety concern, warranting a Moderate severity classification.
Plain-English summary
Ascend Laboratories, LLC is recalling Atorvastatin Calcium Tablets USP, 10 mg distributed nationwide. The recall affects 141,984 bottles in three package sizes: 90-count bottles (NDC 67877-511-90), 500-count bottles (NDC 67877-511-05), and 1000-count bottles (NDC 67877-511-10). The tablets are manufactured by Alkem Laboratories, Ltd. in India and distributed by Ascend Laboratories, LLC in Parsippany, New Jersey.
The recall was initiated due to failed dissolution specifications in specific lot numbers. Dissolution refers to the rate at which a tablet breaks down and releases the active ingredient for absorption. Eight lot numbers are affected, with expiration dates ranging from July 2026 through February 2027: lot numbers 25141249, 24144938, 24144868, 24144867, 24144458, 24143994, 24142987, and 24143316.
Consumers who have obtained affected bottles should contact their pharmacy or healthcare provider for information about obtaining replacement medication. Atorvastatin is a prescription medication used to manage cholesterol levels and reduce cardiovascular risk. Consumers should not discontinue their medication without consulting their doctor.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Ascend Laboratories, LLC
- Hazard
- failed-dissolution-specification
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.
Related recalls
Same brand · ATORVASTATIN CALCIUM
- ModerateAtorvastatin Calcium Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin Calcium tablets recalled nationwide for failed dissolution specifications
FDA (Drugs) · 2025-10-22
- HighAtorvastatin Calcium Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2025-10-22
- HighBiocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications
FDA (Drugs) · 2025-04-09
- HighPrescription atorvastatin bottles recalled for containing wrong medication
FDA (Drugs) · 2024-10-09
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27