CLASS II Drug recall · Reported 23 Dec 2020 · FDA Enforcement Report
Lansoprazole Delayed-Release Orally Disintegrating Tablets recalled
Zydus Pharmaceuticals is recalling Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg ( unit-dose), distributed nationwide in the US. The recall was initiated on 3 Dec 2020 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-0146-2021
- FDA event ID
- 86925
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Lansoprazole
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2020
- FDA classified
- 11 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 3 Dec 2020 | Recall initiated by company | |
| 11 Dec 2020 | Classified by FDA | +8 days |
| 23 Dec 2020 | 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
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
M900412 December 2020 M904772 February 2021 M915745 October 2021
Where was it sold?
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.
Other products in this recall event
1 other product · FDA event 86925This product is part of a recall event; the main page for the event is Lansoprazole Delayed-Release Orally Disintegrating Tablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lansoprazole Delayed-Release Orally Disintegrating Tablets recalledLansoprazole | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Lansoprazole recalls
All 15| 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 Capsules USP, 15 mg recalled | Natco Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) recalledLansoprazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Lansoprazole Delayed-Release Capsules, USP, 30 mg recalledLansoprazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Lansoprazole Delayed-Release Orally Disintegrating Tablets recalledLansoprazole | Zydus Pharmaceuticals | Potency & Assay | Nationwide |