Saline Enema Recalled Due to Manufacturing Practice Deviations
Blossom Pharmaceuticals is recalling Saline Enema (Wecare brand) due to manufacturing deviations. The recall affects 18,912 containers distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The reason for recall is manufacturing practice deviations without any specified health hazard. This is a voluntary, firm-initiated recall, which per the rubric qualifies as a precautionary measure and scores as Moderate (2).
Plain-English summary
Blossom Pharmaceuticals has initiated a voluntary recall of Saline Enema (Wecare brand), manufactured for Dynarex Corporation. The product is a saline solution for rectal administration containing sodium phosphate monobasic and sodium phosphate dibasic, 4.5 fl oz/133 mL.
The recall affects approximately 18,912 containers distributed nationwide in the United States. The affected lot numbers are A022310 (expiration date 2/26), A022335 (expiration date 10/26), A022406 (expiration date 12/27), and A022505 (expiration date 12/27).
The recall was initiated due to deviations from Current Good Manufacturing Practice (cGMP) standards identified in the manufacturing process.
The recalled product
- Product
- SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
- Brand
- SALINE ENEMA
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: A022310
- Exp. Date 2/26
- A022335
- Exp. Date 10/26
- A022406
- Exp Date 12/27 & A022505
- Exp Date 12/27
UPCs (1)
- 0616784471914
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27