Heartburn and acid-reflux medication recalls
12 FDA-recorded recalls of heartburn and acid-reflux medications, most recent Mar 2026 — newest first, straight from the FDA's own database.
The defining event in this class was ranitidine: NDMA — a probable human carcinogen — was detected in ranitidine tablets, capsules and syrups, and the recalls that followed are in the FDA database we reproduce here. The class is also where a 2026 cross-contamination recall originated, when cetirizine allergy tablets were found contaminated with ranitidine. Most other recalls here are ordinary manufacturing or impurity failures on specific lots, and heartburn medicines are among the easiest to replace — if your lot is named, stop using that pack and ask the pharmacist for an alternative.
Pantoprazole Sodium
Class IIDiscoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Hetero Labs Limited (Unit V) · Apr 29, 2026
Famotidine Injection
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Fresenius Kabi USA, LLC · Dec 3, 2025
Sucralfate Tablets
Class IICGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Amerisource Health Services LLC · Oct 22, 2025
Sucralfate Tablets
Class IICGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Amerisource Health Services LLC · Sep 3, 2025
Sucralfate Tablets
Class IICGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Nostrum Laboratories, Inc. · Aug 6, 2025
Omeprazole Delayed-release Capsules
Class IIPresence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Dr. Reddy's Laboratories, Inc. · Jul 23, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 28, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 28, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg
Class IIILabeling: Not Elsewhere Classified - Wrong NDC number
Zydus Pharmaceuticals (USA) Inc · Dec 11, 2024
Lansoprazole Delayed-Release Capsules USP
Class IICGMP Deviations
NATCO Pharma Limited · Apr 17, 2024
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Class IISubpotent Drug: Out of specification for assay
Bausch Health Companies, Inc. · Mar 6, 2024
Lansoprazole Delayed-Release Capsules USP
Class IICGMP 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.
NATCO Pharma Limited · Feb 14, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antidepressant · Antibiotic · Thyroid medication · Allergy and antihistamine · Hormonal and contraceptive · ADHD and stimulant medication · Opioid and pain medication · Seizure and epilepsy medication · Asthma and inhaler. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.