Class II · Moderate risk
Wecare Calasoothe
cGMP deviations
Wecare Enema
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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.
Affected NDC
67777-0402-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Saline Enema Sodium Phosphate Monobasic, Sodium Phosphate Dibasic NDC 67777-0402 |
SODIUM PHOSPHATE, DIBASIC 7 g/118mL; SODIUM PHOSPHATE, MONOBASIC 19 g/118mL | Enema Rectal |
Dynarex Corporation | OTC |
- Recalling firm
- Blossom Pharmaceuticals
- NDC code
- 67777-402-01
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0203-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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