Gabapentin Capsules recall
FDA recall D-0030-2026 · initiated Oct 10, 2025
The Harvard Drug Group LLC recalled Gabapentin Capsules in Oct 2025 — an FDA Class II recall (D-0030-2026) because Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
- Recalling company
- The Harvard Drug Group LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Oct 10, 2025
- FDA report date
- Oct 29, 2025
Frequently asked
- Was Gabapentin Capsules recalled?
- The Harvard Drug Group LLC recalled Gabapentin Capsules in Oct 2025 — an FDA Class II recall (D-0030-2026) because Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Gabapentin Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0030-2026 was: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
- Is a recalled Gabapentin Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gabapentin Capsules are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0030-2026.