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 USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Affected NDC
76282-0405-05
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 76282-0405 |
600 mg/1 | Tablet, Film Coated Oral |
Exelan Pharmaceuticals Inc. | Rx |
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 76282-405-05
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1272-2020 · 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 InvaGen Pharmaceuticals, Inc.
All 2020 recalls
Class I · High risk
Vigabatrin for Oral Solution
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Class III · Low risk
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Defective Container; actuator may improperly function and affect dose delivery.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
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