CLASS III ONGOING Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report

Ranitidine Tablets USP,150 mg recalled by AuroMedics Pharma

AuroMedics Pharma is recalling Ranitidine Tablets USP,150 mg, distributed nationwide in the US. The recall was initiated on 23 Sep 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: NBSB19001DA3, Exp. date 02/2021

Quantity recalled69696 bottles

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-0166-2020
FDA event ID: 83868
Recalling firm: AuroMedics Pharma, East Windsor, NJ
Classification: Class III
Status: Ongoing
Recall initiated: 23 Sep 2019
FDA classified: 29 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Stomach & Acid Reflux Medication

Timeline

23 Sep 2019	Recall initiated by company
29 Oct 2019	Classified by FDA	+36 days
6 Nov 2019	Published in enforcement report	+8 days

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

Reason for recall

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Product as listed by the FDA

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Which lots are affected?

Lot #: NBSB19001DA3, Exp. date 02/2021

Where was it sold?

Nationwide within 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 AuroMedics Pharma

All 36

Reported	Class	Recall	Company	Reason	Where
2 Nov 2022Drug	CLASS II	Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium	AuroMedics Pharma	Potency & Assay	Nationwide
26 Oct 2022Drug	CLASS II	Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium	AuroMedics Pharma	Particulate Matter	Nationwide
12 Oct 2022Drug	CLASS III	Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid	AuroMedics Pharma	Particulate Matter	Nationwide
16 Feb 2022Drug	CLASS I	Polymyxin B for Injection USP per Vial vials recalledPolymyxin B	AuroMedics Pharma	Particulate Matter	Nationwide
10 Feb 2021Drug	CLASS II	Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen	AuroMedics Pharma	Other	Nationwide

Other Ranitidine recalls

All 55

Reported	Class	Recall	Company	Reason	Where
14 Oct 2020Drug	CLASS II	Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	FL, GA
14 Oct 2020Drug	CLASS II	Ranitidine 300 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	FL, GA
18 Mar 2020Drug	CLASS II	Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled	American Health Packaging	Nitrosamine Impurity	Nationwide
18 Mar 2020Drug	CLASS II	Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled	Precision Dose	Nitrosamine Impurity	Nationwide
12 Feb 2020Drug	CLASS II	ranitidine hydrochloride, USP a) bottles recalled	PD-Rx Pharmaceuticals	Nitrosamine Impurity	12 states