Bisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for N-Nitroso Impurity
Unichem Pharmaceuticals recalls Bisoprolol/Hydrochlorothiazide tablets for exceeding N-Nitroso Bisoprolol impurity limits. Lot GBHL24005A (expiration 09/2026) was distributed nationwide and in Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall for N-Nitroso Bisoprolol impurity specification deviation. No illnesses or injuries have been reported. The manufacturing compliance issue with an impurity specification violation places this at high severity without documented adverse events.
Plain-English summary
Unichem Pharmaceuticals USA Inc. is recalling Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg in 100-count bottles due to manufacturing deviations that failed to meet N-Nitroso Bisoprolol impurity specification limits.
The recall was initiated because the affected product failed current Good Manufacturing Practice (cGMP) requirements. The levels of N-Nitroso Bisoprolol in the product exceeded the established specification limits.
Affected product is Lot #GBHL24005A with an expiration date of 09/2026. The product was distributed nationwide in the United States and in Puerto Rico. Patients currently taking medication from the recalled lot should consult their healthcare provider or pharmacist about obtaining a replacement.
Consumers with questions may contact Unichem Pharmaceuticals USA Inc. Patients should not stop taking their medication without consulting a healthcare provider.
The recalled product
- Product
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Category
- Drug
- Hazard
- n-nitroso-impurity
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 # GBHL24005A
- Exp Date: 09/2026
Distribution
Distributed nationwide across the United States.
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