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Class II: temporary or reversible health riskOngoing

Blossom Pharmaceuticals Wecare Enema Recall

Wecare Enema, 4

Blossom Pharmaceuticals

Risk level
Class II
Reported by FDA
Dec 10, 2025
Recall ID
D-0203-2026
Check your lot numberHow we source this data

Summary

Blossom Pharmaceuticals recalled Wecare Enema starting Oct 31, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0203-2026 on Dec 10, 2025. Reason: cGMP deviations. Status: Ongoing.

Why it was recalled

cGMP deviations

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27

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-0203-2026
Classification
Class II
Status
Ongoing
Recall initiated
Oct 31, 2025
FDA report date
Dec 10, 2025
Quantity
18912 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Blossom Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0203-2026, exactly as published.

Show all FDA fields
City
Bardej, Goa
Status
Ongoing
Country
India
Event ID
97935
Address
Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim
Code information
Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27
Report date
Dec 10, 2025
Product type
Drugs
Recall number
D-0203-2026
Classification
Class II
Recalling firm
Blossom Pharmaceuticals
Product quantity
18912 containers
Reason for recall
cGMP deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
USA Nationwide
Recall initiation date
Oct 31, 2025
Initial firm notification
Letter
Center classification date
Dec 2, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0203-2026, published Dec 10, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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