PEG-3350 Oral Solution Recalled for Defective Non-Sealed Pouches
A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III recalls are typically scored 1 or 2. This packaging defect has no reported illnesses or injuries, and the hazard is theoretical. However, the potential for product leakage constitutes a functional packaging defect rather than purely cosmetic, warranting a Moderate classification.
Plain-English summary
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is a prescription medication distributed by Teva Pharmaceuticals USA, Inc. The U.S. Food and Drug Administration issued a Class III recall for this product.
The recall was issued because the product containers—specifically the pouches—may not be properly sealed, which could lead to product leakage and compromise the integrity of the medication.
The recall affects 13,200 cartons with lot number S300542 (expiration date June 30, 2025) that were distributed nationwide in the United States. The manufacturer of the recalled product is Novel Laboratories, Inc. d.b.a. Lupin Somerset.
The recalled product
- Product
- PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID)
- Brand
- PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
- Manufacturer
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Category
- Drug
- Affected units
- 13,200
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 (3)
- Lot #S300542
- exp. date June 30
- 2025
Distribution
Distributed nationwide across the United States.
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