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).
gabapentin 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 FDA. Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
By RecallRadar Editorial Team
Sourced from FDA. Last reviewed March 4, 2026.
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
gabapentin 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 FDA. Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- October 10, 2025
- Last reviewed by RecallRadar
- March 4, 2026
What You Should Do
- 1## 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). Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . What to do:
- 2Stop using the product if your lot/model matches.
- 3Check the FDA notice for specifics.
- 4Follow remedy instructions.
What's Being Recalled
Quoted source excerpt from the official notice.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
| # | Model |
|---|---|
| 1 | Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027. |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
Frequently Asked Questions
Is my gabapentin device affected?
Check the affected models section on this page. The official notice currently lists Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027..
What is the remedy for this recall?
## 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). Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Keep browsing with these internal hubs: gabapentin recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
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Help us improve the accuracy of this recall information.
Quick Info
- Brand
- gabapentin
- Category
- drug
- Source Agency
- FDA
- Announced
- October 10, 2025
- Country
- US
- Status
- Active
Source & Verification
Sourced from FDA. Last reviewed March 4, 2026.
- Official source
- FDA
- Announced by source
- October 10, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Official Resources
Use these primary sources for final eligibility and claim instructions.
Open Official Recall NoticeView official notice from FDAStay Protected
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