CLASS III Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Gabapentin Oral Solution, 250 mg/ (50 mg/mL) in a amber-colored recalled
Akorn is recalling Gabapentin Oral Solution, 250 mg/ (50 mg/mL) in a amber-colored, distributed nationwide in the US. The recall was initiated on 15 Dec 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0211-2018
- FDA event ID
- 78730
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Dec 2017
- FDA classified
- 8 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 15 Dec 2017 | Recall initiated by company | |
| 8 Jan 2018 | Classified by FDA | +24 days |
| 17 Jan 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Product as listed by the FDA
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Which lots are affected?
Batch# 359774; Exp. 09/02/19
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Gabapentin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg , blister pack recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Gabapentin Capsules, USP 300 mg recalledGabapentin | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |