PlainRecordsAtorvastatin Calcium Tablets…
- Reason
- Presence of Foreign Tablets/Capsules
- Status
- Ongoing
- Distribution
- Nationwide in the USA.
- Enforcement report date
- Nov. 4, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- MSN Laboratories Private Limited (Formulations Division, Unit-II)
- 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
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution pattern
- Nationwide in the USA.
- Quantity
- 13,296 1,000-count bottles
- Codes and lots
- Lot: DRF09618A, Exp 08-31-2029, DRG02110A, Exp 01-31-2030.
- Recall started
- Oct. 21, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0113-2027
What the record says about this drug
A simplified drawing of a vial, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Presence of Foreign Tablets/Capsules”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, FDA enforcement report, 2026-11-04. The caption is the record's own words.
A generic vial, not the product. The mark follows the record's own words (a question mark, where used, stands for a lack of assurance the record names, not for anything found).
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
This recall among the others
- FDA's enforcement report came 14 days after the firm started the recall. For half of the 310 FDA drug recall events reported in 2026 so far with a start date, it took 23 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? Medicine recall: what to do · How to read this record
Source: FDA · Drug enforcement report, recall number D-0113-2027. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record D-0113-2027, Nov. 4, 2026. "Atorvastatin Calcium Tablets." PlainRecords, https://plainrecords.com/recall/drug/d-0113-2027/ (on this site since Nov. 11, 2026; as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections