CLASS III Drug recall · Reported 25 May 2016 · FDA Enforcement Report
col-rite (docusate sodium) stool softener softgels, 50 mg recalled
Allegiant Health is recalling col-rite (docusate sodium) stool softener softgels, 50 mg, distributed nationwide in the US. The recall was initiated on 29 Feb 2016 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-0856-2016
- FDA event ID
- 73569
- Recalling firm
- Allegiant Health, Deer Park, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Feb 2016
- FDA classified
- 17 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 29 Feb 2016 | Recall initiated by company | |
| 17 May 2016 | Classified by FDA | +78 days |
| 25 May 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
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
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
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Where it was distributed
Nationwide
Stores named: Rite Aid
Questions about this recall
Why was it recalled?
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Which lots are affected?
Lot #: 5C344105, Exp 02/17
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 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 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.
More recalls from Allegiant Health
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HealthA2Z Chewable Aspirin (Nsaid) 81 mg, Orange Flavor, a) recalled | Allegiant Health | Particulate Matter | Nationwide |
| Drug | CLASS II | Famotidine Tablets, USP, Over the Counter recalled by Allegiant Health | Allegiant Health | Manufacturing (CGMP) Deviations | Nationwide |