FDA Drugs recall ·

Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only… recall

Recall number
D-0113-2027
Date
(initiated October 21, 2026)
Company / brand
MSN Laboratories Private Limited (Formulations Division, Unit-II)
Survey # 1277, 1319-1324, Rangareddy District, India
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
13,296 1,000-count bottles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telangana - 509228, India; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854-3714. NDC: 72205-024-99

Why was it recalled?

Presence of Foreign Tablets/Capsules

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot: DRF09618A, Exp 08-31-2029, DRG02110A, Exp 01-31-2030.

Distribution

Nationwide in the USA.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0113-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.