CLASS III Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Lansoprazole Delayed-Release Orally Disintegrating Tablets recalled
Teva Pharmaceuticals USA is recalling Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg (10 blister cards of, distributed nationwide in the US. The recall was initiated on 11 Mar 2019 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-1006-2019
- FDA event ID
- 82367
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Brand
- Lansoprazole
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Mar 2019
- FDA classified
- 15 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 11 Mar 2019 | Recall initiated by company | |
| 15 Mar 2019 | Classified by FDA | +4 days |
| 27 Mar 2019 | 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
Subpotent Drug.
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, 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 was distributed
Nationwide in the United States.
Questions about this recall
Why was it recalled?
Subpotent Drug.
Which lots are affected?
Lot #: 25Q002, Exp. 11/2019
Where was it sold?
Nationwide in the United States.
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 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.
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Lansoprazole recalls
All 18| 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 |