Atorvastatin Calcium tablets recalled nationwide for failed dissolution specifications
Ascend Laboratories recalls Atorvastatin Calcium 20 mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug 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 a Class II FDA recall for a pharmaceutical quality defect with no reported illnesses, injuries, or deaths. The hazard involves failed dissolution specifications, a manufacturing quality issue affecting drug efficacy rather than acute toxicity.
Plain-English summary
Ascend Laboratories, LLC is recalling Atorvastatin Calcium Tablets USP, 20 mg across the United States. The affected product includes three package sizes: 90-count, 500-count, and 1000-count bottles.
The recall was issued due to failed dissolution specifications. This means the tablets may not dissolve properly in the body, which could affect how the medication is absorbed and its ability to work as intended.
The recall affects multiple lot numbers manufactured by Alkem Laboratories, Ltd. in India and distributed by Ascend Laboratories. Affected lot numbers range from 24142936 through 25140173, with expiration dates from June 2026 through December 2026.
Consumers who have the recalled tablets should not use them. Patients should contact their pharmacy or healthcare provider for a replacement supply.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Hazard
- dissolution-failure
- medication-efficacy
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.
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