CLASS II Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report

Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled

American Health Packaging is recalling Ranitidine Tablets, USP, 150 mg x 10 blister card), distributed nationwide in the US. The recall was initiated on 20 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020

Quantity recalled53,619 cartons

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-1003-2020
FDA event ID: 85070
Recalling firm: American Health Packaging, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2019
FDA classified: 12 Mar 2020
Reported: 18 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Stomach & Acid Reflux Medication

Timeline

20 Nov 2019	Recall initiated by company
12 Mar 2020	Classified by FDA	+113 days
18 Mar 2020	Published in enforcement report	+6 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: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

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

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

Where it was distributed

Nationwide USA

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Which lots are affected?

Lot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020

Where was it sold?

Nationwide USA

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 American Health Packaging

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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 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
12 Feb 2020Drug	CLASS II	Ranitidine Hydrochloride (powder) recalled	Spectrum Laboratory Products	Nitrosamine Impurity	11 states