CLASS III Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report
Lansoprazole Delayed-Release Capsules, USP, 30 mg recalled
Mckesson Packaging Services is recalling Lansoprazole Delayed-Release Capsules, USP, 30 mg, distributed nationwide in the US. The recall was initiated on 8 Sep 2016 and the FDA has classified it as Class III.
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-1550-2016
- FDA event ID
- 75141
- Recalling firm
- Mckesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Sep 2016
- FDA classified
- 28 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 8 Sep 2016 | Recall initiated by company | |
| 28 Sep 2016 | Classified by FDA | +20 days |
| 5 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Product as listed by the FDA
Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10
Where it was distributed
Nationwide
Questions about this recall
Is Lansoprazole Delayed-Release Capsules, USP, 30 mg recalled?
Yes. Mckesson Packaging Services recalled Lansoprazole Delayed-Release Capsules, USP, 30 mg on 8 Sep 2016. The recall is Class III and its status is Terminated. Recall number D-1550-2016.
Why was it recalled?
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Which lots are affected?
Lot # 0111295, Exp 9/17
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Mckesson Packaging Services
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 120 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem CD (Diltiazem Hydrochloride Extended-Release recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg UD recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | 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 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 |