Teva Recalls Amphetamine Tablets Due to Impurity Test Failures
Teva Pharmaceuticals is recalling 9,717 bottles of mixed amphetamine salts tablets because stability testing revealed high impurity levels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a chemical impurity detected during stability testing rather than a known acute toxic event.
Plain-English summary
Teva Pharmaceuticals USA is recalling 9,717 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate tablets. The affected product is a 10 mg, 100-count prescription bottle manufactured by Teva Pharmaceuticals USA in Sellersville, PA. The specific lot number is 34015516A, with an expiration date of 05/16.
The recall was initiated because the product failed impurities/degradation specifications. Specifically, stability testing produced a high out-of-specification test result for impurities. The product was distributed nationwide.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The recall number is D-0566-2016.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9,717
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 34015516A
- Exp 05/16
UPCs (1)
- 305550972020
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- HighAmphetamine salt tablets recalled after bottles contained a lower strength tablet
FDA (Drugs) · 2025-09-17
- HighTeva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling
FDA (Drugs) · 2022-09-21
- ModerateTeva Recalls Mixed Strength Amphetamine Salts Tablets
FDA (Drugs) · 2020-06-10
- ModerateTeva Recalls Mixed Amphetamine Salts Tablets Due to Strength Variations
FDA (Drugs) · 2020-06-10
- HighTeva Recalls Mixed Amphetamine Salts Tablets Due to Mixed Strengths
FDA (Drugs) · 2020-06-10
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17