Why it was recalled
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Product description
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Lot numbers, UPCs & expiration codes
Lot# 34A0054, exp. date 05/07/2026
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0060-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 11, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- 587 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0060-2025, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95659
- Address
- 317 New Boston St
- Code information
- Lot# 34A0054, exp. date 05/07/2026
- Postal code
- 01801-6231
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0060-2025
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 587 boxes
- Reason for recall
- cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Nov 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 19, 2024