Stomach & Acid Reflux Medication recalls

The FDA has published 313 recalls involving stomach & acid reflux medication since 2012. The latest was reported on 9 Sep 2026. Most were for nitrosamine impurity. Dr. Reddy's Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls313since 2012

Last 12 months13reported

Class I114% of total

Ongoing55latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

1Nov '24 1 0 0Feb 0 0 3May 0 2 0Aug 0 0 0Nov 2 1 0Feb 1 6 0May 0 0 1Aug 2 0

Severity split

Class I 11 4%Class II 268 86%Class III 34 11%

Why stomach & acid reflux medication is recalled

Companies

Brands

By year

2026114%
202572%
2024134%
2023124%
2022258%
2021186%
20204815%
20196922%
2018114%
2017114%

Ongoing stomach & acid reflux medication recalls

55 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
12 Aug 2026Drug	CLASS II	Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride	Aurobindo Pharma USA	Packaging Defects	Nationwide
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
15 Apr 2026Drug	CLASS II	Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears	Preferred Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile Eye Drops Soothing Tears recalled by K.C. Pharmaceuticals	K.C. Pharmaceuticals	Sterility	Nationwide

All stomach & acid reflux medication recalls, newest first

313 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
12 Aug 2026Drug	CLASS II	Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride	Aurobindo Pharma USA	Packaging Defects	Nationwide
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
15 Apr 2026Drug	CLASS II	Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears	Preferred Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Sterile Eye Drops Soothing Tears recalled by K.C. Pharmaceuticals	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	EYE Drops Advanced Relief, (dextran recalled by K.C. PharmaceuticalsQuality Choice Moisturizing Relief Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Dry Eye Relief Eye Drops, (glycerin recalled by K.C. PharmaceuticalsArtificial Tears	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026Drug	CLASS II	Ultra Lubricating Eye Drops (polyethylene recalledLeader Ultra Lubricating Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Tears Polyethylene Glycol 400 0.4% w/v recalled	Wizcure Pharmaa Private	Sterility	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
24 Dec 2025Drug	CLASS II	Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled	Preferred Pharmaceuticals	Packaging Defects	CA
3 Dec 2025Drug	CLASS I	Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine	Fresenius Kabi USA	Sterility	Nationwide
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide
2 Jul 2025Drug	CLASS II	Metoclopramide Tablets, USP 10 mg recalled by Teva Pharmaceuticals USAMetoclopramide	Teva Pharmaceuticals USA	Other	Nationwide
28 May 2025Drug	CLASS II	Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium	Zydus Pharmaceuticals	Potency & Assay	Nationwide
28 May 2025Drug	CLASS II	Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium	Zydus Pharmaceuticals	Potency & Assay	Nationwide
14 May 2025Drug	CLASS II	Lubricant Eye Drops Solution recalled by BRS Analytical ServicesLubricant Eye Drops Solution	BRS Analytical Services	Sterility	Nationwide
11 Dec 2024Drug	CLASS III	Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium	Zydus Pharmaceuticals	Packaging Defects	Nationwide
27 Nov 2024Drug	CLASS II	Docusate Sodium 250 mg in blister card-foils unit dose recalled	Safecor Health	Manufacturing (CGMP) Deviations	Nationwide
30 Oct 2024Drug	CLASS II	OneLAX Docusate Sodium Liquid recalled by Akron Pharma	Akron Pharma	Manufacturing (CGMP) Deviations	Nationwide
17 Apr 2024Drug	CLASS II	Lansoprazole Delayed-Release Capsules USP, 15 mg recalled	Natco Pharma	Manufacturing (CGMP) Deviations	Nationwide
6 Mar 2024Drug	CLASS II	Omeprazole and Sodium Bicarbonate For Oral Suspension recalled	Bausch Health Companies	Potency & Assay	Nationwide
14 Feb 2024Drug	CLASS I	Leader Dry Eye Relief (Polyethylene glycol recalledDry Eye Relief	Kilitch Healthcare India	Sterility	Nationwide
14 Feb 2024Drug	CLASS II	Lansoprazole Delayed-Release Capsules USP, 15 mg recalled	Natco Pharma	Manufacturing (CGMP) Deviations	Nationwide
14 Feb 2024Drug	CLASS I	Lubricant Gel Drops (Polyethylene glycol recalled	Kilitch Healthcare India	Sterility	Nationwide
14 Feb 2024Drug	CLASS I	Equate Hydration PF Lubricant Eye Drops recalled	Kilitch Healthcare India	Sterility	Nationwide
14 Feb 2024Drug	CLASS I	CVS Health Lubricating Gel Drops recalled by Kilitch Healthcare India	Kilitch Healthcare India	Sterility	Nationwide
14 Feb 2024Drug	CLASS I	Target High Performance Lubricant Eye Drops recalled	Kilitch Healthcare India	Sterility	Nationwide
3 Jan 2024Drug	CLASS II	Dicyclomine Hydrochloride Tablets, USP 20 mg recalledDicyclomine Hydrochloride	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Stomach & Acid Reflux Medication?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.

Alert me about Stomach & Acid Reflux Medication

One email the day a new recall is posted for Stomach & Acid Reflux Medication. Unsubscribe any time.

At a glance

Latest recall: 9 Sep 2026
First on record: 11 Jul 2012
Class I share: 4%
Ongoing: 55

Drug classes

Injectable & IV Drugs 4,627Pain Medication 1,518Creams, Ointments & Gels 930Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 495Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.