CLASS II Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report

Ranitidine Tablets, USP 300 mg recalled by AVKARE

Avkare is recalling Ranitidine Tablets, USP 300 mg, distributed nationwide in the US. The recall was initiated on 14 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021

Quantity recalled104,797 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-0525-2020
FDA event ID: 84287
Recalling firm: Avkare, Pulaski, TN
Classification: Class II
Status: Terminated
Recall initiated: 14 Nov 2019
FDA classified: 26 Nov 2019
Reported: 4 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Stomach & Acid Reflux Medication

Timeline

14 Nov 2019	Recall initiated by company
26 Nov 2019	Classified by FDA	+12 days
4 Dec 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: Impurity N-nitrosodimethylamine (NDMA) found in API

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Which lots are affected?

Lots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021

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.

Other products in this recall event

1 other product · FDA event 84287

This product is part of a recall event; the main page for the event is Ranitidine Tablets, USP 150 mg recalled by AVKARE.

Reported	Class	Recall	Company	Reason	Where
4 Dec 2019	CLASS II	Ranitidine Tablets, USP 150 mg recalled by AVKARE	Avkare	Nitrosamine Impurity	Nationwide

More recalls from Avkare

All 62

Reported	Class	Recall	Company	Reason	Where
4 Mar 2026Drug	CLASS II	Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl	AvKARE	Potency & Assay	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	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