CLASS II Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report
Senna Syrup (sennosides) 8 mg recalled by Pharmatech
Pharmatech is recalling Senna Syrup (sennosides) 8 mg, distributed nationwide in the US. The recall was initiated on 8 Aug 2016 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-1526-2016
- FDA event ID
- 74874
- Recalling firm
- Pharmatech, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2016
- FDA classified
- 27 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 8 Aug 2016 | Recall initiated by company | |
| 27 Sep 2016 | Classified by FDA | +50 days |
| 5 Oct 2016 | Published in enforcement report | +8 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: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Product as listed by the FDA
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
Where it was distributed
Nationwide
Questions about this recall
Is Senna Syrup (sennosides) 8 mg recalled?
Yes. Pharmatech recalled Senna Syrup (sennosides) 8 mg on 8 Aug 2016. The recall is Class II and its status is Terminated. Recall number D-1526-2016.
Why was it recalled?
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which lots are affected?
Lot #: 20391517, Exp 09/17; 20391518, Exp10/17; 20391519, Exp 11/17; 20391601, Exp 01/18; 20391602, Exp 02/18; 20391604, 20391605, Exp 03/18; 20391608, Exp 06/18
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 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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