Teva Recalls Fluoxetine Tablets Due to Impurity Test Failures
Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a failed impurity specification discovered during routine testing, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots of Fluoxetine Tablets USP, 10 mg, 30-count bottles within their expiration dates. The recall was initiated after routine stability testing activities produced an out-of-specification (OOS) test result for the lactoside impurity.
The affected product is manufactured in Israel by Teva Pharmaceuticals IND, LTD and distributed throughout the United States. The recall covers 1,157,095 bottles. The specific NDC for the product is 0093-7188-56.
Consumers and healthcare providers should check their inventory for this specific product and NDC number. If the product is found, it should be returned to the pharmacy or supplier for disposal or credit in accordance with standard recall procedures.
The recalled product
- Product
- Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,157,095
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 (1)
- All lots within expiry.
Distribution
Distribution scope not specified by the agency.
Related recalls
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