CLASS III Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg* recalled
Dr. Reddy's Laboratories is recalling Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) bottle (, distributed nationwide in the US. The recall was initiated on 6 Feb 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0995-2019
- FDA event ID
- 82065
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Manufacturer
- Dr. Reddy's Laboratories Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Feb 2019
- FDA classified
- 12 Mar 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 6 Feb 2019 | Recall initiated by company | |
| 20 Feb 2019 | Published in enforcement report | +14 days |
| 12 Mar 2019 | Classified by FDA | +20 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Product as listed by the FDA
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.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Which lots are affected?
Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Esomeprazole recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium | Zydus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalledEsomeprazole Magnesium | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg recalledEsomeprazole Magnesium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |