Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Is Dextroamphetamine recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Dextroamphetamine (48 total). Check the affected lots below.
Most common reason: Labeling / mix-up (22 of these recalls)
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.
Dextroamphetamine recalls in 2026
1 initiated in 2026, 48 in total — newest first
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:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class II · Moderate risk
Dextroamphetamine Saccharate
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Class II · Moderate risk
Xelstrym (dextroamphetamine)
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class I · High risk
Zenzedi (Dextroamphetamine Sulfate)
Labeling: Label Mix-up
Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Sacharate
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
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