Promethazine Syrup Plain Recall Due to Microbial Contamination
Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.
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: This is an FDA Class II recall involving a CGMP deviation with potential microbial contamination. The source text does not report any actual illnesses, injuries, or hospitalizations, and the hazard is described as a potential concern rather than a confirmed harm. This meets the rubric criterion for a Moderate severity recall.
Plain-English summary
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, manufactured by Morton Grove Pharmaceuticals, Inc. (for Wockhardt USA, LLC) is being recalled nationwide and in China. The recall affects 116,400 bottles with lot numbers UV1335, UV1352, and UV1373 (NDC: 60432-608-16).
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, there is a potential concern with products manufactured using liquid sugar batches that were contaminated with microbial organisms.
Patients and healthcare providers who have this medication should contact their healthcare provider for guidance. Consumers should not use affected bottles and should contact the manufacturer or their pharmacy for instructions on return or disposal.
The recalled product
- Product
- Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Prescription Liquid
- Hazard
- microbial-contamination
- cgmp-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 (3)
- Lot #: UV1335
- UV1352
- and UV1373
Distribution
Distributed nationwide across the United States.
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