CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Senna (sennosides 8 mg) Syrup recalled by Geritrex
Geritrex is recalling Senna (sennosides 8 mg) Syrup, 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
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-1437-2019
- 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. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Senna (sennosides 8 mg) Syrup recalled?
Yes. Geritrex recalled Senna (sennosides 8 mg) Syrup on 6 May 2019. The recall is Class II and its status is Terminated. Recall number D-1437-2019.
Why was it recalled?
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Which lots are affected?
Lot #: 1806031, 1806014, 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 21 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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