Recalls / Class II
Class IID-0203-2026
Product
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
- Brand name
- Saline Enema
- Generic name
- Sodium Phosphate Monobasic, Sodium Phosphate Dibasic
- Active ingredients
- Sodium Phosphate, Dibasic, Sodium Phosphate, Monobasic
- Route
- Rectal
- NDC
- 67777-402
- FDA application
- M007
- Affected lot / code info
- Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Blossom Pharmaceuticals
- Manufacturer
- Dynarex Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, N/A, India
Distribution
- Quantity
- 18912 containers
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-02
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0203-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.