Teva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures
Teva Pharmaceuticals is recalling 9,882 bottles of Dextroamphetamine Sulfate 10 mg tablets because stability testing revealed out-of-specification impurities.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be lower.
Plain-English summary
Teva Pharmaceuticals USA is recalling 9,882 bottles of Dextroamphetamine Sulfate Tablets, USP, 10 mg. The affected product is identified by Lot # 34013122A and has an expiration date of 11/15. The NDC number for the recalled product is 0555-0953-02.
The recall was initiated because the product failed impurities/degradation specifications. Specifically, stability testing resulted in an out-of-specification test result for impurities. The agency has classified this as a Class II recall.
The affected bottles were distributed nationwide and in Puerto Rico. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SULFATE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Stimulant
- Hazard
- Affected units
- 9,882
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 # 34013122A
- Exp 11/15
Distribution
Related recalls
Same brand · DEXTROAMPHETAMINE SULFATE
- ModerateActavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
FDA (Drugs) · 2016-08-03
- ModerateActavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
FDA (Drugs) · 2015-03-11
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 · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateTeva Recalls Amphetamine Tablets Due to Impurity Test Failures
FDA (Drugs) · 2016-01-20
- SevereTeva Recalls Dextroamphetamine Tablets Due to Unknown Impurities
FDA (Drugs) · 2014-11-05
- HighTeva Recalls Amphetamine Tablets Due to Unknown Impurity
FDA (Drugs) · 2015-08-12
- ModerateTeva Recalls Dextroamphetamine Tablets Due to CGMP Deviations
FDA (Drugs) · 2014-03-12
- ModerateTeva Recalls Mixed Amphetamine Salts Tablets Due to Strength Variations
FDA (Drugs) · 2020-06-10
- ModerateTeva Recalls Mixed Strength Amphetamine Salts Tablets
FDA (Drugs) · 2020-06-10