CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report

Senna (sennosides 8.8 mg) Syrup recalled by Geritrex

Geritrex is recalling Senna (sennosides 8.8 mg) Syrup, Rij Pharmaceuticals Corporation 40 Commercial Avenue, distributed nationwide in the US. The recall was initiated on 6 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 1804012, Exp. 08/2019

Quantity recalled1536 units

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-1436-2019
FDA event ID: 82947
Recalling firm: Geritrex, Middletown, NY
Classification: Class II
Status: Terminated
Recall initiated: 6 May 2019
FDA classified: 28 Jun 2019
Reported: 19 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

6 May 2019	Recall initiated by company
19 Jun 2019	Published in enforcement report	+44 days
28 Jun 2019	Classified by FDA	+9 days

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

Reason for recall

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Which lots are affected?

Lot #: 1804012, Exp. 08/2019

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 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 82947

This product is part of a recall event; the main page for the event is Senna (sennosides 8.8 mg) Syrup recalled by Geritrex.

Reported	Class	Recall	Company	Reason	Where
19 Jun 2019	CLASS II	Senna (sennosides 8.8 mg) Syrup recalled by Geritrex	Geritrex	Potency & Assay	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
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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	Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg recalled by Geritrex	Geritrex	Sterility	Nationwide

Other Senna (sennosides recalls

All 4

Reported	Class	Recall	Company	Reason	Where
26 Jan 2022Drug	CLASS I	Senna Syrup (sennosides) 8.8 mg/ unit-dose cups recalled by Lohxa	Lohxa	Sterility	Nationwide
19 Jun 2019Drug	CLASS II	Senna (sennosides 8.8 mg) Syrup recalled by Geritrex	Geritrex	Potency & Assay	Nationwide
5 Oct 2016Drug	CLASS II	Senna Syrup (sennosides) 8.8 mg recalled by Pharmatech	Pharmatech	Manufacturing (CGMP) Deviations	Nationwide