Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Yes — there is an active recall. 7 ongoing FDA recalls mention Dextroamphetamine (48 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dextroamphetamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
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