Teva Recalls Terazosin Hydrochloride Capsules Due to Labeling Error
Teva Pharmaceuticals is recalling 6,267 bottles of Terazosin Hydrochloride capsules because the 10 mg label contained 5 mg capsules.
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, and the hazard is a labeling error regarding drug strength. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 6,267 bottles of Terazosin Hydrochloride Capsules, 10 mg, 100-count, Rx only. The product is identified by NDC 0093-4339-01, Lot # N07321, and an expiration date of 6/14.
The recall was initiated due to a labeling error where unopened, sealed bottles labeled as containing 10 mg capsules actually contained 5 mg capsules. This discrepancy could result in patients receiving a lower dose than prescribed.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,267
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 # N07321
- Exp 6/14
Distribution
Related recalls
Same manufacturer · Teva Pharmaceuticals USA, Inc.
See all →- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.2 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02