Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Atorvastatin Calcium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
75834-0257-01
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 75834-0257 |
ATORVASTATIN 40 mg/1 | Tablet Oral |
Nivagen Pharmaceuticals, INC. | Rx |
- Recalling firm
- Nivagen Pharmaceuticals Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0001-2025 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 USP 40 mg
Failed dissolution specifications: lower than specifications
Other particulate / foreign matter recalls from 2024
All particulate / foreign matter recalls
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
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