Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Lansoprazole recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Lansoprazole (25 total). Check the affected lots below.

Most common reason: Dissolution failure (10 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Lansoprazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Lansoprazole recalls on record

none so far in 2026; 25 on record, newest first
Class II · Moderate risk

Lansoprazole Delayed-Release Capsules USP

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Terminated Packaging defect NATCO Pharma Limited NDC 16571-742-41 D-0318-2024
Class II · Moderate risk

Preferred Pharmaceuticals

Out of specification results observed in dissolution during long term stability testing.

Terminated Dissolution failure Preferred Pharmaceuticals, Inc. NDC 68788-6390-09 D-0769-2022
Class III · Low risk

Lansoprazole Delayed-Release Capsules

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.

Terminated Labeling / mix-up Mckesson Packaging Services NDC 63739-0555-10 D-1550-2016
Class II · Moderate risk

Lansoprazole 3 mg/mL Susp

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1056-2015
Class II · Moderate risk

Lansoprazole active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-748-2015
Class II · Moderate risk

triple therapy

Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

Terminated Impurity / degradation Teva Pharmaceuticals USA NDC 0093-8055-78 D-1499-2014