Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Gabapentin Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Affected NDC
50228-0177-05
Compare with the code on your package — it is the most precise check available.
Drug: Gabapentin Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Gabapentin NDC 50228-0177 |
600 mg/1 | Tablet Oral |
ScieGen Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0354-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Gabapentin recalls
See all
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Tablets 600mg
CGMP Deviations
Other recalls by Sciegen Pharmaceuticals Inc
All 2023 recalls
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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