CLASS III Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Gabapentin Tablets, USP 600 mg recalled by Sciegen Pharmaceuticals
Sciegen Pharmaceuticals is recalling Gabapentin Tablets, USP 600 mg per, distributed nationwide in the US. The recall was initiated on 17 Feb 2023 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-0354-2023
- FDA event ID
- 91717
- Recalling firm
- Sciegen Pharmaceuticals, Hauppauge, NY
- Brand
- Gabapentin
- Manufacturer
- ScieGen Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Feb 2023
- FDA classified
- 27 Feb 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 17 Feb 2023 | Recall initiated by company | |
| 27 Feb 2023 | Classified by FDA | +10 days |
| 8 Mar 2023 | 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
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Product as listed by the FDA
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Which lots are affected?
Lot # G177092, Exp. 11/24
Where was it sold?
Nationwide in the USA and Puerto Rico
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.
More recalls from Sciegen Pharmaceuticals
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Westminister Irbesartan Tablets, USP, 300mg recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 300 mg,(a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 75 mg recalled by Sciegen Pharmaceuticals | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminister Irbesartan Tablets, USP, 150 mg, (a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
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 |