RecallRadar

FDA Drug recall D-0420-2018

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

On 2018-02-07 the FDA classified a Class III recall of Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-… by Dr Reddy S Laboratories, citing failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0420-2018
ClassificationClass III
Statusterminated
Initiated2018-01-29
Published2018-02-07
Last updated2026-09-13 11:52 UTC
CompanyDr Reddy S Laboratories
DistributionUS

Product

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

Reason

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

Identifiers

ndc55111-121-30
ndc55111-121-60
ndc55111-121-90
ndc55111-121-05
ndc55111-121-10
ndc55111-122-30
ndc55111-122-60
ndc55111-122-90
ndc55111-122-05
ndc55111-122-10
ndc55111-123-30
ndc55111-123-60
ndc55111-123-90
ndc55111-123-05
ndc55111-123-10
code_infoLot number: T600279, 6/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0420-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.