LowClass IIITerminated

FDA Drug recall · Reported April 4, 2018

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.

Q: Which agency issued this recall?

This recall was issued by the FDA Drug on April 4, 2018. Severity: Low. Recall number: D-0611-2018.

Q: Where was the recalled product distributed?

Distribution: Nationwide in the USA.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Recall #: D-0611-2018
Affected scope: 56,1800 unit dose cups
Initiated: March 29, 2018

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Drug →

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Akorn, Inc. recalled Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packag… - a low-severity action.

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packag… was recalled by Akorn, Inc. in April 4, 2018. Reason: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine …. Check the official notice for the remedy. Verify recall #D-0611-2018 with the FDA Drug before acting.

The recall

Akorn, Inc. issued this low-severity FDA Drug recall-Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine ….

Low
severity level: 562K units
affected scope: Class III
classification: April 4, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0611-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.

Reason for recall

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-0611-2018
Date reported	April 4, 2018
Date initiated	March 29, 2018
Recalling firm	Akorn, Inc.
Firm location	Lake Forest, IL
Affected scope	56,1800 unit dose cups
Distribution	Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

56,1800 unit dose cups units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0611-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 4, 2018. Severity: Low. Recall number: D-0611-2018.

Where was the recalled product distributed? ▼

Distribution: Nationwide in the USA.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

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Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported April 4, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026