Atorvastatin Calcium Tablets USP 40 mg recall
FDA recall D-0306-2025 · initiated Mar 17, 2025
BIOCON PHARMA INC recalled Atorvastatin Calcium Tablets USP 40 mg in Mar 2025 — an FDA Class II recall (D-0306-2025) because Failed dissolution specifications: lower than specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed dissolution specifications: lower than 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.
Quantity recalled: 2184 bottles
Details
- Product
- Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
- Recalling company
- Biocon Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. nationwide
- Initiated
- Mar 17, 2025
- FDA report date
- Apr 9, 2025
Frequently asked
- Was Atorvastatin Calcium Tablets USP 40 mg recalled?
- BIOCON PHARMA INC recalled Atorvastatin Calcium Tablets USP 40 mg in Mar 2025 — an FDA Class II recall (D-0306-2025) because Failed dissolution specifications: lower than specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Atorvastatin Calcium Tablets USP 40 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0306-2025 was: Failed dissolution specifications: lower than specifications
- Is a recalled Atorvastatin Calcium Tablets USP 40 mg 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 40 mg are affected?
- Distributed: U.S.A. nationwide. The recall covers these lots — Lot#: AVC24035, Exp 03/31/26. 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-0306-2025.