Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Reported: October 29, 2025 Initiated: October 10, 2025 #D-0031-2026
Product Description
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Reason for Recall
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Details
- Recalling Firm
- The Harvard Drug Group LLC
- Distribution
- US Nationwide.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).. Recalled by The Harvard Drug Group LLC.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 29, 2025. Severity: Moderate. Recall number: D-0031-2026.
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