PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported February 12, 2020

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.

Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calci…

Recall #
D-0832-2020
Affected scope
29,056 bottles
Initiated
January 28, 2020
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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Graviti Pharmaceuticals Private Limited recalled Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Bi… - a moderate-severity action.

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Bi… was recalled by Graviti Pharmaceuticals Private Limited in February 12, 2020. Reason: Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was prese…. Check the official notice for the remedy. Verify recall #D-0832-2020 with the FDA Drug before acting.

The recall

Graviti Pharmaceuticals Private Limited issued this moderate-severity FDA Drug recall-Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was prese….

Moderate
severity level
Class II
classification
February 12, 2020
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0832-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0832-2020) was formally reported on February 12, 2020, with the manufacturer initiating the action on January 28, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Graviti Pharmaceuticals Private Limited is listed as the recalling firm, operating out of Medak, N/A. Federal records list the affected scope as 29,056 bottles.

The documented reason for this recall is: Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg. Distribution data in the federal record shows the product reached: 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, 5 from FDA Drug - 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.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

29,056 bottles

Related Recalls

6

5 from same agency

Product description

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.

Reason for recall

Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0832-2020
Date reported February 12, 2020
Date initiated January 28, 2020
Recalling firm Graviti Pharmaceuticals Private Limited
Firm location Medak, N/A
Affected scope 29,056 bottles
Distribution 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-0832-2020) 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, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.. Recalled by Graviti Pharmaceuticals Private Limited. Units affected: 29,056 bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 12, 2020. Severity: Moderate. Recall number: D-0832-2020.
Where was the recalled product distributed?
Distribution: Nationwide in the USA..
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0832-2020) 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.

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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 February 12, 2020. 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.