Dextroamphetamine Saccharate recall
FDA recall D-0672-2025 · initiated Aug 28, 2025
Granules Pharmaceuticals Inc. recalled Dextroamphetamine Saccharate in Aug 2025 — an FDA Class III recall (D-0672-2025) because Failed Impurities/Degradation Specifications:.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 11,909 bottles
Details
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
- Recalling company
- Granules Pharmaceuticals Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Aug 28, 2025
- FDA report date
- Oct 1, 2025
Frequently asked
- Was Dextroamphetamine Saccharate recalled?
- Granules Pharmaceuticals Inc. recalled Dextroamphetamine Saccharate in Aug 2025 — an FDA Class III recall (D-0672-2025) because Failed Impurities/Degradation Specifications:. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Dextroamphetamine Saccharate recalled?
- Per the FDA enforcement record, the reason for recall D-0672-2025 was: Failed Impurities/Degradation Specifications:
- Is a recalled Dextroamphetamine Saccharate 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 Dextroamphetamine Saccharate are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — Lot#: GPC250179A, Exp Date: 06-22-2027. 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-0672-2025.