Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported March 11, 2015
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Akorn, Inc. recalled Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with ne… - a moderate-severity action.
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with ne… was recalled by Akorn, Inc. in March 11, 2015. Reason: Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.. Check the official notice for the remedy. Verify recall #D-0405-2015 with the FDA Drug before acting.
The recall
Akorn, Inc. issued this moderate-severity FDA Drug recall-Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride..
- Moderate
- severity level
- Class II
- classification
- March 11, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0405-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0405-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on February 27, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Akorn, Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 44,448 bottles.
The documented reason for this recall is: Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. Distribution scope 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
44,448 bottles
Related Recalls
6
0 from same agency
Product description
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.
Reason for recall
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0405-2015 |
| Date reported | March 11, 2015 |
| Date initiated | February 27, 2015 |
| Recalling firm | Akorn, Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 44,448 bottles |
| 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-0405-2015) 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? ▼
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.. Recalled by Akorn, Inc.. Units affected: 44,448 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2015. Severity: Moderate. Recall number: D-0405-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0405-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 11, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.