Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported September 5, 2018
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Akorn, Inc. recalled Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx… - a low-severity action.
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx… was recalled by Akorn, Inc. in September 5, 2018. Reason: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide. Check the official notice for the remedy. Verify recall #D-1168-2018 with the FDA Drug before acting.
The recall
Akorn, Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide.
- Low
- severity level
- Class III
- classification
- September 5, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1168-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1168-2018) was formally reported on September 5, 2018, with the manufacturer initiating the action on August 8, 2018. It is classified under Low severity (Class III), 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 8,574 bottles.
The documented reason for this recall is: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide Distribution data in the federal record shows the product reached: Nationwide USA. 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, 5 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,574 bottles
Related Recalls
6
5 from same agency
Product description
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Reason for recall
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1168-2018 |
| Date reported | September 5, 2018 |
| Date initiated | August 8, 2018 |
| Recalling firm | Akorn, Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 8,574 bottles |
| Distribution | Nationwide USA |
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-1168-2018) 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? ▼
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10. Recalled by Akorn, Inc.. Units affected: 8,574 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2018. Severity: Low. Recall number: D-1168-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1168-2018) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 September 5, 2018. 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.