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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71984

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 13, 2015
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Dr. Reddy's Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 7

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.

D-1373-2015
Recall number
D-1373-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
1,056 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

Lot #: C403575, Expiry: 10/2015

Distribution pattern

U.S. Nationwide

drug · product 2 of 7

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.

D-1374-2015
Recall number
D-1374-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
576 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

Lot #: C403574, Expiry: 10/2015

Distribution pattern

U.S. Nationwide

drug · product 3 of 7

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.

D-1375-2015
Recall number
D-1375-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
984 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

Lot #: C402341, Expiry: 08/2015

Distribution pattern

U.S. Nationwide

drug · product 4 of 7

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.

D-1376-2015
Recall number
D-1376-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
a) 14,640 and b) 624 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015.

Distribution pattern

U.S. Nationwide

drug · product 5 of 7

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

D-1377-2015
Recall number
D-1377-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
a) 16,080 and b) 480 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

a) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015

Distribution pattern

U.S. Nationwide

drug · product 6 of 7

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.

D-1378-2015
Recall number
D-1378-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
a) 16,848 and b) 216 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016

Distribution pattern

U.S. Nationwide

drug · product 7 of 7

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.

D-1379-2015
Recall number
D-1379-2015
Initiated
August 13, 2015
Classification
Class III
Status
Terminated
Quantity
3840 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Subpotent atorvastatin.

Code information

Lot #: C404595, Expiry: 11/2015

Distribution pattern

U.S. Nationwide