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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79065

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

Open FDA event record

Event summary

Timeline bucket
January 29, 2018
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

3 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 3

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

D-0418-2018
Recall number
D-0418-2018
Initiated
January 29, 2018
Classification
Class III
Status
Terminated
Quantity
a) 34,125; b) 3,540 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Code information

Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018

Distribution pattern

Nationwide

drug · product 2 of 3

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

D-0419-2018
Recall number
D-0419-2018
Initiated
January 29, 2018
Classification
Class III
Status
Terminated
Quantity
a) 28,941 and b) 2,928 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Code information

Lot numbers: a) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018

Distribution pattern

Nationwide

drug · product 3 of 3

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

D-0420-2018
Recall number
D-0420-2018
Initiated
January 29, 2018
Classification
Class III
Status
Terminated
Quantity
12,579 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Code information

Lot number: T600279, 6/2018

Distribution pattern

Nationwide

Field note

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