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.
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 2/5 (Moderate).
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.…
- 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
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