Atorvastatin Calcium Tablets recall
FDA recall D-0001-2025 · initiated Sep 24, 2024
Nivagen Pharmaceuticals Inc recalled Atorvastatin Calcium Tablets in Sep 2024 — an FDA Class II recall (D-0001-2025) because Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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.
Quantity recalled: 2328 bottles
Details
- Product
- Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
- Recalling company
- Nivagen Pharms Inc
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Sep 24, 2024
- FDA report date
- Oct 9, 2024
Frequently asked
- Was Atorvastatin Calcium Tablets recalled?
- Nivagen Pharmaceuticals Inc recalled Atorvastatin Calcium Tablets in Sep 2024 — an FDA Class II recall (D-0001-2025) because Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Atorvastatin Calcium Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0001-2025 was: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
- Is a recalled Atorvastatin Calcium Tablets 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 are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot #: U24T0408A, Exp: 03/31/2026. 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-0001-2025.