Atorvastatin Calcium Tablets USP recall
FDA recall D-0018-2026 · initiated Sep 19, 2025
Ascend Laboratories, LLC recalled Atorvastatin Calcium Tablets USP in Sep 2025 — an FDA Class II recall (D-0018-2026) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Sep 19, 2025
- FDA report date
- Oct 22, 2025
Frequently asked
- Was Atorvastatin Calcium Tablets USP recalled?
- Ascend Laboratories, LLC recalled Atorvastatin Calcium Tablets USP in Sep 2025 — an FDA Class II recall (D-0018-2026) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Atorvastatin Calcium Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0018-2026 was: Failed Dissolution Specifications
- Is a recalled Atorvastatin Calcium Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Atorvastatin Calcium Tablets USP are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0018-2026.