FDA recall, , Moderate risk
MSN Laboratories Atorvastatin Calcium Tablets
Atorvastatin Calcium Tablets contain foreign tablets or capsules.
Summary by Recall Canary from the FDA notice
What happened
MSN Laboratories Private Limited (Formulations Division, Unit-II), located in Rangareddy District, India, initiated a voluntary recall of Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, due to the presence of foreign tablets or capsules. The product was distributed nationwide in the USA by Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854-3714, and manufactured by MSL Laboratories Private Limited, Telangana - 509228, India.
The recall began on October 21, 2026, and customers were notified by letter. The FDA classified the recall on October 29, 2026, and it was added to the agency's Enforcement Report the same day. The recall was included in the FDA's weekly enforcement report on November 4, 2026.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Atorvastatin Calcium Tablets, USP, 40mg
- NDC
- 72205-024-99
- Lot code
- DRF09618A
- DRG02110A
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide in the USA.
- Recalled by
- MSN Laboratories Private Limited (Formulations Division, Unit-II)Rangareddy District, India
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100172
- Recall number
- D-0113-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from MSN Laboratories Private Limited (Formulations Division, Unit-II)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
MSN Laboratories Private began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
