HIGH

Granules Pharmaceuticals Recalls Dextroamphetamine Capsules Over Contamination Risk

Granules Pharmaceuticals Inc. recalled 9,917 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The product failed impurities and degradation specifications, posing potential health risks. Consumers should stop using the capsules immediately and consult healthcare providers for guidance.

Hazard Information

Failed Impurities/Degradation Specifications:

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: E-Mail

Product Details

Granules Pharmaceuticals manufactured 15 mg extended-release capsules of Dextroamphetamine, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate. The product, identified by NDC 70010-031-01, was distributed nationwide in the USA.

The Hazard

The recalled capsules failed to meet impurities and degradation specifications. This class III recall indicates a high hazard level, potentially affecting patient safety.

Reported Incidents

No specific incidents or injuries have been reported at this time. The recall is precautionary based on testing results.

What to Do

Stop using the recalled capsules immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance on next steps.

Contact Information

For further assistance, reach Granules Pharmaceuticals at their email provided in recall notifications. Additional information can be found on the FDA website.

Key Facts

  • Recall date: August 28, 2025
  • Reported by: Granules Pharmaceuticals Inc.
  • Total quantity recalled: 9,917 bottles
  • NDC: 70010-031-01
  • Expiration date: June 22, 2027
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeExtended-Release Capsules
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot#: GPC250178A
Exp Date: 06-22-2027
UPC Codes
70010-029
70010-030
70010-031
+9 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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