Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Atorvastatin Calcium Tablets USP 40 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications: lower than specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDC
70377-0079-13
Compare with the code on your package — it is the most precise check available.
Drug: Atorvastatin Category: Cholesterol Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Atorvastatin Calcium NDC 70377-0079 |
TRIHYDRATE 40 mg/1 | Tablet, Film Coated Oral |
Biocon Pharma Inc. | Rx |
- Recalling firm
- Biocon Pharma INC
- NDC code
- 70377-079-13
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0306-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Atorvastatin recalls
See all
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets
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.
Other recalls by Biocon Pharma INC
All 2025 recalls
Class II · Moderate risk
Posaconazole Delayed-Release Tablets
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
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