CLASS III Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) recalled
Braintree Laboratories is recalling Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx). The recall was initiated on 15 Jul 2013 and the FDA has classified it as Class III.
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-911-2013
- FDA event ID
- 65676
- Recalling firm
- Braintree Laboratories, Holbrook, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Jul 2013
- FDA classified
- 20 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 15 Jul 2013 | Recall initiated by company | |
| 20 Aug 2013 | Classified by FDA | +36 days |
| 28 Aug 2013 | 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
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
Where it was distributed
Nationwie
Questions about this recall
Is Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) recalled?
Yes. Braintree Laboratories recalled Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) on 15 Jul 2013. The recall is Class III and its status is Terminated. Recall number D-911-2013.
Why was it recalled?
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Which lots are affected?
Lot 3013002 Exp. 08/14
Where was it sold?
Nationwie
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.