CLASS II Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Docusate Sodium, 100mg softgels recalled by Rx Pak Division of McKesson
Rx Pak Division of McKesson is recalling Docusate Sodium, 100mg softgels, distributed nationwide in the US. The recall was initiated on 16 Jan 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-1007-2019
- FDA event ID
- 81943
- Recalling firm
- Rx Pak Division of McKesson, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2019
- FDA classified
- 15 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 16 Jan 2019 | Recall initiated by company | |
| 15 Mar 2019 | Classified by FDA | +58 days |
| 27 Mar 2019 | Published in enforcement report | +12 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: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
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
Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
Where it was distributed
Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
Questions about this recall
Why was it recalled?
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Which lots are affected?
Lot # 0119397, Exp 02/2020
Where was it sold?
Product was distributed to 5 major distributors who may have further distributed the product throughout 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 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.
Other Docusate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Docusate Sodium 250 mg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Sankaijo Botanical Laxative (docusate sodium 8.33 mg recalledSankaijo | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS I | Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding | US Compounding | Sterility | TX |
| Drug | CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Docusate Calcium, Capsule, 240 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |