Gabapentin Capsules recall
FDA recall D-0508-2025 · initiated Jun 19, 2025
The Harvard Drug Group LLC recalled Gabapentin Capsules in Jun 2025 — an FDA Class II recall (D-0508-2025) because Defective container; blister packaging inadequately sealed.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container; blister packaging inadequately sealed.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
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.
Quantity recalled: 3,527 bags
Details
- Product
- Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
- Recalling company
- The Harvard Drug Group LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Jun 19, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was Gabapentin Capsules recalled?
- The Harvard Drug Group LLC recalled Gabapentin Capsules in Jun 2025 — an FDA Class II recall (D-0508-2025) because Defective container; blister packaging inadequately sealed. 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-0508-2025 was: Defective container; blister packaging inadequately sealed.
- 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: Nationwide. The recall covers these lots — Lot# M05205A and M05205B, Exp Date 10/2026.. 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-0508-2025.