Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7.

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

Recall #: D-1290-2014
Affected scope: 1,530 kits
Initiated: March 10, 2014

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

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AbbVie Inc recalled Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit wit… - a moderate-severity action.

Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit wit… was recalled by AbbVie Inc in May 7, 2014. Reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc…. Check the official notice for the remedy. Verify recall #D-1290-2014 with the FDA Drug before acting.

The recall

AbbVie Inc issued this moderate-severity FDA Drug recall-Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc….

Moderate
severity level: Class II
classification: May 7, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1290-2014 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

Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7.

Reason for recall

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

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-1290-2014
Date reported	May 7, 2014
Date initiated	March 10, 2014
Recalling firm	AbbVie Inc
Firm location	North Chicago, IL
Affected scope	1,530 kits
Distribution	Nationwide and Puerto Rico

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-1290-2014) 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? ▼

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 7, 2014. Severity: Moderate. Recall number: D-1290-2014.

Where was the recalled product distributed? ▼

Distribution: Nationwide and Puerto Rico.

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

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Similar severity · nearest report date

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This recall: FDA Drug, reported May 7, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026