Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0814-2021·Announced 2021-09-29

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: 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
Affected units: 116,400

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.

Part of a larger recall action

This product is one of 3 recalled by Morton Grove Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Morton Grove Pharmaceuticals, Inc.

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Same hazard · microbial contamination