CLASS II Drug recall · Reported 11 Nov 2020 · FDA Enforcement Report
Lansoprazole Delayed-Release Orally Disintegrating Tablets recalled
Zydus Pharmaceuticals is recalling Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg carton ( unit-dose), distributed nationwide in the US. The recall was initiated on 27 Oct 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-0075-2021
- FDA event ID
- 86663
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Lansoprazole
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Oct 2020
- FDA classified
- 10 Nov 2020
- Reported
- 11 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 27 Oct 2020 | Recall initiated by company | |
| 10 Nov 2020 | Classified by FDA | +14 days |
| 11 Nov 2020 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification
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-count carton (10 x10 unit-dose), 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
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specification
Which lots are affected?
Lot # M005682, EXP 3/2022
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 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 86663This 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 |