HIGH

Granules Pharmaceuticals Recalls Amphetamine Capsules Over Impurity Risks

Granules Pharmaceuticals recalled 11,928 bottles of amphetamine capsules on August 28, 2025. The recall follows failure to meet impurities and degradation specifications. Consumers should stop using the product immediately and contact their healthcare providers.

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

The recall involves Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, 30 mg, 100 capsules per bottle. The affected lot number is GPC250181A, with an expiration date of June 19, 2027. The product was distributed nationwide in the USA.

The Hazard

The capsules failed impurities and degradation specifications, posing a potential health risk. Impurities in medications can affect their efficacy and safety.

Reported Incidents

No specific incidents or injuries have been reported in connection with this recall. The recall was classified as Class III, indicating a possible health hazard but not likely to cause serious adverse health consequences.

What to Do

Stop using the recalled product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for further guidance. Consumers can reach out via email for assistance.

Contact Information

For questions regarding the recall, consumers can contact Granules Pharmaceuticals Inc. directly. Additional information is available on the FDA website.

Key Facts

  • Recall date: August 28, 2025
  • Reported date: October 1, 2025
  • Quantity recalled: 11,928 bottles
  • Manufacturer: Granules Pharmaceuticals Inc.
  • Impurity risk identified in capsules
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
GPC250181A
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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