CLASS II Drug recall · Reported 8 Jan 2020 · FDA Enforcement Report

Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL recalled

American Health Packaging is recalling Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/ per cup, distributed nationwide in the US. The recall was initiated on 1 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes[Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021

Quantity recalled1,692 cases of 40 and 50 cups

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-0631-2020
FDA event ID: 84208
Recalling firm: American Health Packaging, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 1 Nov 2019
FDA classified: 29 Dec 2019
Reported: 8 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Stomach & Acid Reflux Medication

Timeline

1 Nov 2019	Recall initiated by company
29 Dec 2019	Classified by FDA	+58 days
8 Jan 2020	Published in enforcement report	+10 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: Presence of NDMA impurity detected in product.

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 Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

Where it was distributed

Nationwide USA

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

Which lots are affected?

[Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021

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 (ranitidine recalls

All 6

Reported	Class	Recall	Company	Reason	Where
4 Dec 2019Drug	CLASS II	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL recalled	Lannett	Nitrosamine Impurity	Nationwide
13 Apr 2016Drug	CLASS III	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled	Bio-pharm	Potency & Assay	Nationwide
11 Nov 2015Drug	CLASS III	Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg recalled	Vintage Pharmaceuticals LLC	Potency & Assay	Nationwide
7 Aug 2013Drug	CLASS II	Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL recalled	Actavis South Atlantic	Potency & Assay	Nationwide