Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Recall #: D-0995-2019
Affected scope: 40,592, 90 and 1,000 count bottles
Initiated: February 6, 2019

Compiled from official public sources by the publisher. · Updated September 2026

Dr. Reddy's Laboratories, Inc. recalled Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598… - a low-severity action.

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598… was recalled by Dr. Reddy's Laboratories, Inc. in February 20, 2019. Reason: Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.. Check the official notice for the remedy. Verify recall #D-0995-2019 with the FDA Drug before acting.

The recall

Dr. Reddy's Laboratories, Inc. issued this low-severity FDA Drug recall-Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets..

Low
severity level: Class III
classification: February 20, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0995-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 1 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Reason for recall

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-0995-2019
Date reported	February 20, 2019
Date initiated	February 6, 2019
Recalling firm	Dr. Reddy's Laboratories, Inc.
Firm location	Princeton, NJ
Affected scope	40,592, 90 and 1,000 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-0995-2019) 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? ▼

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 40,592, 90 and 1,000 count bottles.

Why was this product recalled? ▼

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0995-2019.

Where was the recalled product distributed? ▼

Distribution: Distributed Nationwide in the USA.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

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This recall: FDA Drug, reported February 20, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026