CLASS II Drug recall · Reported 27 Oct 2021 · FDA Enforcement Report
Omeprazole Delayed-Release Capsules, 20 mg* recalled
Dr. Reddy's Laboratories is recalling Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), distributed nationwide in the US. The recall was initiated on 5 Oct 2021 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-0026-2022
- FDA event ID
- 88809
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Acid Reducer
- Manufacturer
- LEADER/ Cardinal Health 110, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2021
- FDA classified
- 22 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 5 Oct 2021 | Recall initiated by company | |
| 22 Oct 2021 | Classified by FDA | +17 days |
| 27 Oct 2021 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Product as listed by the FDA
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Which lots are affected?
BT001594C
Where was it sold?
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 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 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 Omeprazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Omeprazole and Sodium Bicarbonate For Oral Suspension recalledOmeprazole And Sodium Bicarbonate | Bausch Health Companies | Potency & Assay | 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 |