Ascend Recalls Tamsulosin Hydrochloride Capsules Due to Dissolution Failure
Ascend Laboratories is recalling 3,072 bottles of Tamsulosin Hydrochloride 0.4 mg capsules because stability testing revealed high out-of-specification dissolution results.
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 typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a dangerous substance, and no injuries or illnesses are reported.
Plain-English summary
Ascend Laboratories LLC is recalling 3,072 bottles of Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles. The product is a prescription-only medication manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories in Parsippany, NJ. The affected product is identified by Lot # 8144652 with an expiration date of July 2020.
The recall was initiated because high out-of-specification dissolution results were observed during stability testing. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the expected rate in the body. When dissolution fails to meet specifications, the medication may not work as intended.
The affected product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discontinued and returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)
- Brand
- TAMSULOSIN HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Prescription Drug
- Affected units
- 3,072
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 #: 8144652
- Exp Jul 2020
Distribution
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