Lansoprazole recalls: 11 FDA reports
Recalls involving Lansoprazole. What was wrong with each batch, and how the FDA graded the risk.
11Reports
0Class I
0Ongoing
2022-08-03Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of
D-1287-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- FAILED DISSOLUTION SPECIFICATIONS
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
- Where it went
- Nationwide in the USA
- How much
- 2,892 cartons
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of
D-1288-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- FAILED DISSOLUTION SPECIFICATIONS
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78
- Where it went
- Nationwide in the USA
- How much
- 2,639 cartons
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets pe
D-0853-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
- Where it went
- OH
- How much
- 252 Blister Packs
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Labo
D-0738-2022 · Class II · reported 2022-04-06 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; during long term stability testing.
- Product
- Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.
- Where it went
- Nationwide in the USA
- How much
- 7,703 bottles
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle,
D-0737-2022 · Class II · reported 2022-04-06 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; during long term stability testing.
- Product
- Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
- Where it went
- Nationwide in the USA
- How much
- 8,352 bottles (30-count), 1,368 bottles (90-count)
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack,
D-0145-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
- Where it went
- Nationwide
- How much
- 15,144 cartons
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pac
D-0146-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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 went
- Nationwide
- How much
- 22,848 cartons
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only
D-0074-2021 · Class II · reported 2020-11-11 · Terminated
- Why it was recalled
- Failed Dissolution Specification
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 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 68382-771-77
- Where it went
- Distributed Nationwide in the USA
- How much
- 6,840 units
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only
D-0075-2021 · Class II · reported 2020-11-11 · Terminated
- Why it was recalled
- Failed Dissolution Specification
- Product
- 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 went
- Distributed Nationwide in the USA
- How much
- 7,908 units
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets
D-1006-2019 · Class III · reported 2019-03-27 · Terminated
- Why it was recalled
- Subpotent Drug.
- Product
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
- Where it went
- Nationwide in the United States.
- How much
- 7,081 bottles
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: M
D-147-2013 · Class II · reported 2013-02-13 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
- Product
- Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
- Where it went
- Nationwide
- How much
- 1,894 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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