CLASS II Drug recall · Reported 14 Aug 2024 · FDA Enforcement Report
Gabapentin Tablets, USP, 600 mg recalled by Granules Pharmaceuticals
Granules Pharmaceuticals is recalling Gabapentin Tablets, USP, 600 mg, distributed nationwide in the US. The recall was initiated on 31 Jul 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0634-2024
- FDA event ID
- 95072
- Recalling firm
- Granules Pharmaceuticals, Chantilly, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2024
- FDA classified
- 14 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 31 Jul 2024 | Recall initiated by company | |
| 14 Aug 2024 | Classified by FDA | +14 days |
| 14 Aug 2024 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Which lots are affected?
Lot 1380040A, Exp. date July 31, 2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 24 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Granules Pharmaceuticals
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride | Granules Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
Other Gabapentin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg , blister pack recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Gabapentin Capsules, USP 300 mg recalledGabapentin | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |