CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report

Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg recalled by Geritrex

Geritrex is recalling Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/, RIJ Pharmaceutical Corporation 40, distributed nationwide in the US. The recall was initiated on 31 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 70606, Exp 6/19

Quantity recalled8645 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-1520-2019
FDA event ID: 83200
Recalling firm: Geritrex, Middletown, NY
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2019
FDA classified: 25 Jul 2019
Reported: 31 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Allergy Medication

Timeline

31 May 2019	Recall initiated by company
25 Jul 2019	Classified by FDA	+55 days
31 Jul 2019	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: Products may have microbial contamination.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04

Where it was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

cGMP Deviations: Products may have microbial contamination.

Which lots are affected?

Lot #: 70606, Exp 6/19

Where was it sold?

U.S.A. 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

7 other products · FDA event 83200

This product is part of a recall event; the main page for the event is Preferred Plus Dioctyl Liquid Stool Softener recalled by Geritrex.

Reported	Class	Recall	Company	Reason	Where
31 Jul 2019	CLASS II	Preferred Plus Dioctyl Liquid Stool Softener recalled by Geritrex	Geritrex	Sterility	Nationwide
31 Jul 2019	CLASS II	Gericare Geri-Tussin DM, Geri-care Phamaceuticals Corp recalled	Geritrex	Sterility	Nationwide
31 Jul 2019	CLASS II	Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg recalled	Geritrex	Sterility	Nationwide
31 Jul 2019	CLASS II	Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg recalled	Geritrex	Sterility	Nationwide
31 Jul 2019	CLASS II	Ritussin DM Double Strength recalled by Geritrex	Geritrex	Sterility	Nationwide
31 Jul 2019	CLASS II	Ritussin DM Children & Adults recalled by Geritrex	Geritrex	Sterility	Nationwide
31 Jul 2019	CLASS II	Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg recalled	Geritrex	Sterility	Nationwide

More recalls from Geritrex

All 15

Reported	Class	Recall	Company	Reason	Where
31 Jul 2019Drug	CLASS II	Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg recalled	Geritrex	Sterility	Nationwide
31 Jul 2019Drug	CLASS II	Ritussin DM Children & Adults recalled by Geritrex	Geritrex	Sterility	Nationwide
31 Jul 2019Drug	CLASS II	Ritussin DM Double Strength recalled by Geritrex	Geritrex	Sterility	Nationwide
31 Jul 2019Drug	CLASS II	Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg recalled	Geritrex	Sterility	Nationwide
31 Jul 2019Drug	CLASS II	Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg recalled	Geritrex	Sterility	Nationwide