HIGH

Dynarex Recalls Wecare Enema Due to Safety Violations

Dynarex Corporation recalled 18,912 containers of Wecare Enema on October 31, 2025, due to cGMP deviations. Consumers should stop using the product immediately. The recall affects products distributed nationwide in the USA.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
SALINE ENEMA, Dynarex Corporation
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

cGMP deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recalled product is Wecare Enema, 4.5 Fl Oz/133mL, manufactured for Dynarex Corporation. The recalled lot numbers include A022310, A022335, A022406, and A022505, with various expiration dates.

The Hazard

The recall follows deviations from current Good Manufacturing Practices (cGMP). Such violations can compromise the safety and efficacy of the product.

Reported Incidents

There have been no reported injuries associated with this recall. The company initiated the recall proactively due to manufacturing concerns.

What to Do

Stop using the Wecare Enema immediately. Contact Blossom Pharmaceuticals or your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0203-2026.

Key Facts

  • Recalled product: Wecare Enema, 4.5 Fl Oz/133mL
  • Total units recalled: 18,912 containers
  • Manufactured by: Dynarex Corporation in India
  • Reason for recall: cGMP deviations
  • Recall date: October 31, 2025

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: A022310
Exp. Date 2/26
A022335
Exp. Date 10/26
A022406
+2 more
UPC Codes
67777-402
67777-402-01
67777-402-02
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more