CLASS II Drug recall · Reported 12 Sep 2012 · FDA Enforcement Report

Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops recalled

Medtech Products is recalling Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, distributed nationwide in the US. The recall was initiated on 20 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 11338, Exp 04/13
Quantity recalled12,720 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-1673-2012
FDA event ID
62402
Recalling firm
Medtech Products, Irvington, NY
Classification
Class II
Status
Terminated
Recall initiated
20 Jun 2012
FDA classified
6 Sep 2012
Reported
12 Sep 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

20 Jun 2012Recall initiated by company
6 Sep 2012Classified by FDA+78 days
12 Sep 2012Published 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

Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.

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

Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.

Which lots are affected?

Lot # 11338, Exp 04/13

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.

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