CLASS III Drug recall · Reported 27 May 2020 · FDA Enforcement Report
Gabapentin Tablets USP, 600 mg recalled by InvaGen Pharmaceuticals
InvaGen Pharmaceuticals is recalling Gabapentin Tablets USP, 600 mg, distributed nationwide in the US. The recall was initiated on 14 May 2020 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-1272-2020
- FDA event ID
- 85646
- Recalling firm
- InvaGen Pharmaceuticals, Hauppauge, NY
- Brand
- Gabapentin
- Manufacturer
- Exelan Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 May 2020
- FDA classified
- 21 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 14 May 2020 | Recall initiated by company | |
| 21 May 2020 | Classified by FDA | +7 days |
| 27 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Which lots are affected?
Lot # NB900413, Exp. 12/2020
Where was it sold?
Nationwide in the U.S.
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 InvaGen Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin | InvaGen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Testosterone Topical Solution 30mg of testosterone per pump recalledTestosterone | InvaGen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200 mg/mL recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 2000 mg/ (200 mg/mL) recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 1000 mg/ (100 mg/mL) recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | 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 |