Gabapentin Tablets recall
FDA recall D-0634-2024 · initiated Jul 31, 2024
Granules Pharmaceuticals Inc. recalled Gabapentin Tablets in Jul 2024 — an FDA Class II recall (D-0634-2024) because Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 11,808 500-count Bottles
Details
- Product
- Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
- Recalling company
- Granules Pharmaceuticals Inc
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jul 31, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was Gabapentin Tablets recalled?
- Granules Pharmaceuticals Inc. recalled Gabapentin Tablets in Jul 2024 — an FDA Class II recall (D-0634-2024) because Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Gabapentin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0634-2024 was: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
- Is a recalled Gabapentin Tablets 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 Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 1380040A, Exp. date July 31, 2025. 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-0634-2024.