Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported March 10, 2021
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Dr. Reddy's Laboratories, Inc. recalled Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b)… - a low-severity action.
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b)… was recalled by Dr. Reddy's Laboratories, Inc. in March 10, 2021. Reason: Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy…. Check the official notice for the remedy. Verify recall #D-0291-2021 with the FDA Drug before acting.
The recall
Dr. Reddy's Laboratories, Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy….
- Low
- severity level
- Class III
- classification
- March 10, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0291-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0291-2021) was formally reported on March 10, 2021, with the manufacturer initiating the action on February 19, 2021. It is classified under Low severity (Class III), with a current status of Terminated. Dr. Reddy's Laboratories, Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 10,440 90-count and 224,710 500-count bottles.
The documented reason for this recall is: Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Outdoor & Sports recalls over time
Where this recall sits in its category - 510 outdoor & sports recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,440 90-count and 224,710 500-count bottles
Related Recalls
6
0 from same agency
Product description
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Reason for recall
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0291-2021 |
| Date reported | March 10, 2021 |
| Date initiated | February 19, 2021 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Firm location | Princeton, NJ |
| Affected scope | 10,440 90-count and 224,710 500-count bottles |
| Distribution | Distributed Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0291-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 10,440 90-count and 224,710 500-count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 10, 2021. Severity: Low. Recall number: D-0291-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0291-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Topyond Pool Drain Ports with Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazar…
Changsha Jiali Duo Technology Co., Ltd., dba Topyond, of China · 2026-07-02
CPSC Moderate
Spa Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia…
Shenzhen Fuxiangyue Technology Co., Ltd., dba Arrogantf, of China · 2026-06-18
CPSC Moderate
Houoto 642-2150V Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards…
Foshan Nanhai District Haichen Tengfei Hardware Factory, of China · 2026-06-11
CPSC Moderate
Joyin Recalls Sloosh Dive Sticks Due to Risk of Serious Injury from Impalement; Violate Federal Dive Sticks Ban
· 2026-06-11
CPSC Moderate
Bicycle Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicyc…
Dongguanshizhouhedianzishangwuyouxiangongsi (Dongguan Zhouhe E-commerce Co., Ltd.) dba Gudook Outdoor Sports, of China · 2026-06-04
Compare this recall with Topyond Pool Drain Ports with Covers Recalled Due to Risk o… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 10, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.