CLASS II ONGOING Drug recall · Reported 23 Jul 2025 · FDA Enforcement Report
Omeprazole Delayed-release Capsules, USP, 20mg recalled
Dr. Reddy's Laboratories is recalling Omeprazole Delayed-release Capsules, USP, 20mg, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class II.
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-0525-2025
- FDA event ID
- 97161
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Omeprazole
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2025
- FDA classified
- 14 Jul 2025
- Reported
- 23 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 30 Jun 2025 | Recall initiated by company | |
| 14 Jul 2025 | Classified by FDA | +14 days |
| 23 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Product as listed by the FDA
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Which lots are affected?
Lot: C2403017, Exp 12/31/2026
Where was it sold?
USA Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 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 |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
Other Omeprazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole and Sodium Bicarbonate For Oral Suspension recalledOmeprazole And Sodium Bicarbonate | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, 20 mg* recalledAcid Reducer | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral recalledPrilosec | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Omeprazole Delayed Release Capsules, USP, 20 mg recalled | Golden State Medical Supply | Potency & Assay | PA, TX |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, USP, 20 mg recalled | Breckenridge Pharmaceutical | Potency & Assay | Nationwide |