The Harvard Drug Group LLC 2025-10-29 Health serious FDA
Health · FDA · Recall #FDA-D-0031-2026
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged… Recall
Issued October 29, 2025 · The Harvard Drug Group LLC
In October 2025, The Harvard Drug Group LLC recalled the Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
What you should do
- 1 Stop using Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Harvard Drug Group LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- The Harvard Drug Group LLC
- Category
- Health
- Recall date
- October 29, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-D-0031-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- The Harvard Drug Group LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.