Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported March 24, 2021
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Akorn, Inc. recalled Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tr… - a moderate-severity action.
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tr… was recalled by Akorn, Inc. in March 24, 2021. Reason: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 mon…. Check the official notice for the remedy. Verify recall #D-0301-2021 with the FDA Drug before acting.
The recall
Akorn, Inc. issued this moderate-severity FDA Drug recall-Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 mon….
- Moderate
- severity level
- 8K units
- affected scope
- Class II
- classification
- March 24, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0301-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0301-2021) was formally reported on March 24, 2021, with the manufacturer initiating the action on March 8, 2021. 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 8,183 unit dose cups.
The documented reason for this recall is: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing 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 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
8,183 unit dose cups
Related Recalls
6
5 from same agency
Product description
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Reason for recall
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0301-2021 |
| Date reported | March 24, 2021 |
| Date initiated | March 8, 2021 |
| Recalling firm | Akorn, Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 8,183 unit dose cups |
| 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-0301-2021) 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? ▼
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07. Recalled by Akorn, Inc.. Units affected: 8,183 unit dose cups.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Moderate. Recall number: D-0301-2021.
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-0301-2021) 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.
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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 March 24, 2021. 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.