fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Recall #: D-0889-2018
Affected scope: 100 syringes
Initiated: June 20, 2018

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

Advanced Pharma Inc. recalled fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled sy… - a moderate-severity action.

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled sy… was recalled by Advanced Pharma Inc. in July 4, 2018. Reason: Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.. Check the official notice for the remedy. Verify recall #D-0889-2018 with the FDA Drug before acting.

The recall

Advanced Pharma Inc. issued this moderate-severity FDA Drug recall-Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label..

Moderate
severity level: Class II
classification: July 4, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0889-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. 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 moderate severity.

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

Product description

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

Reason for recall

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0889-2018
Date reported	July 4, 2018
Date initiated	June 20, 2018
Recalling firm	Advanced Pharma Inc.
Firm location	Houston, TX
Affected scope	100 syringes
Distribution	Distributed to one medical center in Fort Worth, TX.

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

What to do with this recall

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

Check the recall number (D-0889-2018) 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: final drug concentration is subpotent as compared to the concentration indicated on the label.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 4, 2018. Severity: Moderate. Recall number: D-0889-2018.

Where was the recalled product distributed? ▼

Distribution: Distributed to one medical center in Fort Worth, TX..

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 (Moderate), 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 July 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