Teva Recalls Mixed Amphetamine Salts Tablets Due to Strength Variations
Teva Pharmaceuticals is recalling 41,348 bottles of 15 mg Mixed Amphetamine Salts tablets because some bottles may contain mixed strengths.
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 may cause temporary or medically reversible adverse health consequences. The hazard involves potential dosing errors due to mixed strengths, which is a significant quality issue but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause harm).
Plain-English summary
Teva Pharmaceuticals USA is recalling 41,348 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Amphetamine Salts Product), 15 mg, 100 count bottles. The recall is being conducted because some bottles may contain mixed strengths of the product.
The affected product is identified by Lot # 42617008 with an expiration date of 10/2021. The product was distributed nationwide within the United States and Puerto Rico. The NDC for the specific product description is 0555-0777-02.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on how to proceed.
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 Stimulant
- Affected units
- 41,348
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 #: 42617008
- Exp. date 10/2021
Distribution
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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
- HighTeva Recalls Mixed Amphetamine Salts Tablets Due to Mixed Strengths
FDA (Drugs) · 2020-06-10
- ModerateTeva Recalls Mixed Strength Amphetamine Salts Tablets
FDA (Drugs) · 2020-06-10
- ModerateAurobindo Recalls Amphetamine Mixed Salts Tablets for Out-of-Specification Weight
FDA (Drugs) · 2019-10-23
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