CLASS II Drug recall · Reported 17 Apr 2024 · FDA Enforcement Report
Lansoprazole Delayed-Release Capsules USP, 15 mg recalled
NATCO Pharma is recalling Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent, distributed nationwide in the US. The recall was initiated on 27 Mar 2024 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-0438-2024
- FDA event ID
- 94296
- Recalling firm
- NATCO Pharma, Rangareddy, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Mar 2024
- FDA classified
- 5 Apr 2024
- Reported
- 17 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 27 Mar 2024 | Recall initiated by company | |
| 5 Apr 2024 | Classified by FDA | +9 days |
| 17 Apr 2024 | Published in enforcement report | +12 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
Product as listed by the FDA
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Where it was distributed
Nationwide in the US
Questions about this recall
Is Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent recalled?
Yes. NATCO Pharma recalled Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent on 27 Mar 2024. The recall is Class II and its status is Terminated. Recall number D-0438-2024.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot#: 411988, Exp date: 05/31/2025
Where was it sold?
Nationwide in the US
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 21 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 NATCO Pharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lansoprazole Delayed-Release Capsules USP, 15 mg recalled | NATCO Pharma | Manufacturing (CGMP) Deviations | Nationwide |
Other Lansoprazole recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lansoprazole Delayed-Release Capsules USP, 15 mg recalled | NATCO Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lansoprazole Delayed-Release Orally Disintegrating Tablets recalledLansoprazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Lansoprazole Delayed-Release Orally Disintegrating Tablets recalledLansoprazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Lansoprazole Delayed-Release Orally Disintegrating Tablets recalledLansoprazole | Dr. Reddy's Laboratories | Potency & Assay | OH |
| Drug | CLASS II | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) recalledLansoprazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |