Amlodipine Besylate And Atorvastatin C

Amlodipine Besylate And Atorvastatin Calcium recalls: 11 FDA reports

Recalls involving Amlodipine Besylate And Atorvastatin Calcium. What was wrong with each batch, and how the FDA graded the risk.

11Reports
0Class I
0Ongoing
2015-09-02Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class III11
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by

D-1379-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.
Where it went
U.S. Nationwide
How much
3840 Bottles

Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by

D-1375-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.
Where it went
U.S. Nationwide
How much
984 Bottles

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598

D-1377-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
Where it went
U.S. Nationwide
How much
a) 16,080 and b) 480 Bottles

Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-

D-1376-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Where it went
U.S. Nationwide
How much
a) 14,640 and b) 624 Bottles

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-

D-1378-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Where it went
U.S. Nationwide
How much
a) 16,848 and b) 216 Bottles

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by

D-1373-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.
Where it went
U.S. Nationwide
How much
1,056 Bottles

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by

D-1374-2015  ·  Class III  ·  reported 2015-09-02  ·  Terminated

Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.
Where it went
U.S. Nationwide
How much
576 Bottles

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-3

D-1143-2015  ·  Class III  ·  reported 2015-06-24  ·  Terminated

Why it was recalled
Subpotent drug
Product
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Where it went
Nationwide

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-

D-1144-2015  ·  Class III  ·  reported 2015-06-24  ·  Terminated

Why it was recalled
Subpotent drug
Product
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Where it went
Nationwide

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr.

D-1145-2015  ·  Class III  ·  reported 2015-06-24  ·  Terminated

Why it was recalled
Subpotent drug
Product
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90
Where it went
Nationwide

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30

D-1146-2015  ·  Class III  ·  reported 2015-06-24  ·  Terminated

Why it was recalled
Subpotent drug
Product
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Where it went
Nationwide
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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