CLASS II Drug recall · Reported 17 Dec 2014 · FDA Enforcement Report

Famotidine Injection 20 mg recalled by Baxter Healthcare

Baxter Healthcare is recalling Famotidine Injection 20 mg, distributed nationwide in the US. The recall was initiated on 24 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: NC082768, Exp 12/23/2014

NDC0338-5197

Quantity recalled19,152 Containers

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-0293-2015
FDA event ID: 68171
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Famotidine
Manufacturer: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2014
FDA classified: 10 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Stomach & Acid Reflux Medication

Timeline

24 Apr 2014	Recall initiated by company
10 Dec 2014	Classified by FDA	+230 days
17 Dec 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Product as listed by the FDA

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: NC082768, Exp 12/23/2014

Where was it sold?

Nationwide

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 Baxter Healthcare

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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Drug	CLASS II	Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

Other Famotidine recalls

All 15

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
3 Dec 2025Drug	CLASS I	Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine	Fresenius Kabi USA	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	Famotidine Tablets, USP, 20mg bottle within recalledFamotidine	Glenmark Therapeutics	Other	Nationwide
10 Mar 2021Drug	CLASS II	Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine	Aurobindo Pharma USA	Other	4 states
29 Jul 2020Drug	CLASS III	Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition CoFamotidine	HF Acquisition	Temperature Abuse	CT