Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Dextroamphetamine Saccharate
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Affected NDC
70010-0031-01
Compare with the code on your package — it is the most precise check available.
Drug: Dextroamphetamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate NDC 70010-0031 |
DEXTROAMPHETAMINE SACCHARATE 3.75 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg/1; DEXTROAMPHETAMINE SULFATE 3.75 mg/1; AMPHETAMINE SULFATE 3.75 mg/1 | Capsule, Extended Release Oral |
Granules Pharmaceuticals Inc. | Rx · CII |
- Recalling firm
- Granules Pharmaceuticals Inc.
- NDC code
- 70010-031-01
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0671-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Dextroamphetamine recalls
See all
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Other recalls by Granules Pharmaceuticals Inc.
All 2025 recalls
Class II · Moderate risk
Trazodone Hydrochloride
Presence of Foreign Tablets/Capsules
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
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