Teva Recalls Dutasteride and Tamsulosin HCl Capsules for Dissolution Failures
Teva Pharmaceuticals is recalling specific lots of Dutasteride and Tamsulosin HCl capsules because they failed dissolution specifications.
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 is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a failure to meet quality specifications (dissolution) rather than a direct physical injury or contamination.
Plain-English summary
Teva Pharmaceuticals USA is recalling 140,993 bottles of Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/0.4 mg. The affected products are packaged in 30-count and 90-count bottles and were distributed nationwide in the USA and Puerto Rico.
The recall was initiated because the medication failed to meet dissolution specifications. Dissolution testing ensures that a drug releases its active ingredients at the correct rate; failing these tests means the medication may not work as intended.
Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for a replacement. The affected lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippan
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 140,993
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 (20)
- Lot Numbers: a) 1089376A
- 1089382A
- 1095210M
- 1117768M
- 1117769A
- Exp. 11/17
- 1128452A
- 1128453A
- 1137658A
- 1154207A
- 1156087A
- Exp. 03/18
- b) 1089379A
- 1091533M
- 1125206A
- 1128456A
- 1147665A
- 1154208A
- 1156088A
- Exp. 03/18.
Distribution
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 · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17