Agency classClass IIOur severity:High FDA (Drugs)·D-0306-2025·Announced 2025-04-09

Biocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications

Biocon Pharma is recalling 2,184 bottles of Atorvastatin Calcium Tablets USP 40 mg nationwide. The product failed to meet required dissolution specifications, which may affect medication absorption.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall due to failed dissolution specifications that could impact proper medication absorption. No illnesses or injuries have been reported. Classified as High because the manufacturing defect creates a risk of harm through compromised therapeutic efficacy, even though no confirmed adverse events have been documented.

Plain-English summary

Biocon Pharma Inc. is recalling Atorvastatin Calcium Tablets USP 40 mg in 1,000-count bottles. The affected product was manufactured by Recipharm Pharmaservices PVT, Ltd in Bengaluru, India, and distributed nationwide in the United States. The recall affects 2,184 bottles with Lot Number AVC24035 and expiration date March 31, 2026, with NDC 70377-079-13.

The recall was initiated because the product failed to meet required dissolution specifications. Dissolution is the rate at which a tablet breaks down and releases its active ingredient. When dissolution specifications are not met, the medication may not be properly absorbed in the body.

Patients currently taking this medication should check with their pharmacy to determine whether they have received product from the affected lot. Patients should not discontinue their medication without consulting their healthcare provider. Those with product from the affected lot should discuss options with their pharmacy for obtaining alternate product.

The recalled product

Product: ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand: ATORVASTATIN CALCIUM
Manufacturer: BIOCON PHARMA INC
Category: Drug — Prescription / Statin
Hazard: failed-dissolution
bioavailability-defect
Affected units: 2,184

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 (2)

Lot#: AVC24035
Exp 03/31/26

UPCs (1)

0370377080111

Distribution

Distributed nationwide across the United States.

Same brand · ATORVASTATIN CALCIUM

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