The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0799-2023·Announced 2023-06-07

Dicyclomine Hydrochloride Injectable Drug Recalled for Manufacturing Quality Deviations

Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.

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: FDA Class II recall involving manufacturing quality deviations and incomplete stability verification. No illnesses, adverse events, or deaths are reported. The hazard is theoretical rather than a confirmed product defect.

Plain-English summary

Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL ampules. The product is a prescription injectable medication distributed nationwide in the USA and Puerto Rico by Akorn Operating Company, LLC, based in Gurnee, Illinois.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the stability studies required for pharmaceutical products. Stability testing verifies that a drug maintains its safety and effectiveness over its shelf life.

All lots of this product are included in the recall, which has been classified by the FDA as a Class II recall.

The recalled product

Product
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectables
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, 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 86 products in this recall →

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