Dextroamphetamine Salts Recall: Granules Pharmaceuticals 70010-034-01
FDA recall notice for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 30 mg, 100-count, Rx only, manufactured by Granules Pharmaceuticals Inc., due to failed Impurities/Degradation Specifications. The recall involves 11,928 bottles distributed nationwide in the United States. The affected lot is GPC250181A with expiration date 06-19-2027.
| Brand | Granules Pharmaceuticals Inc. |
|---|---|
| Product | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01 |
| Reason | Failed Impurities/Degradation Specifications: |
| Severity | low |
| Units affected | 71424 |
| Distribution | Distributed Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any remaining tablets from the recalled lot.
- Contact your pharmacy or healthcare provider for guidance and possible replacement.
- If you have the recalled lot, arrange for return or disposal according to the recall notice or pharmacy instructions.
- Monitor for adverse symptoms and report any concerns to your doctor or the FDA MedWatch program if applicable.
How to identify the recalled item
| Lot / date codes | Lot#: GPC250181A, Exp Date: 06-19-2027 |
|---|---|
| Lot / date codes | Batch # 6160008A, Exp Date: 12/31/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.