CLASS III Drug recall · Reported 20 Jan 2016 · FDA Enforcement Report
Life-Line Docusate Calcium Sodium Free Stool Softener recalled
National Vitamin is recalling Life-Line Docusate Calcium Sodium Free Stool Softener 240 mg each per, distributed nationwide in the US. The recall was initiated on 18 Dec 2015 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-0568-2016
- FDA event ID
- 72893
- Recalling firm
- National Vitamin, Casa Grande, AZ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Dec 2015
- FDA classified
- 12 Jan 2016
- Reported
- 20 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 18 Dec 2015 | Recall initiated by company | |
| 12 Jan 2016 | Classified by FDA | +25 days |
| 20 Jan 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
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Product as listed by the FDA
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Which lots are affected?
Lot #: 5EA46, 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 National Vitamin
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Nature's Blend Folic Acid 1000 mcg Dietary Supplement recalledNature's Blend | National Vitamin | Other | 19 states |
| Food | CLASS II | Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg recalledFerrous Gluconate | National Vitamin | Labeling Errors | Nationwide |