Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Bisoprolol Fumarate and Hydrochlorothiazide tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Affected NDC
29300-0187-01
Compare with the code on your package — it is the most precise check available.
Drug: Hydrochlorothiazide Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| bisoprolol fumarate and hydrochlorothiazide NDC 29300-0187 |
HYDROCHLOROTHIAZIDE 6.25 mg/1; BISOPROLOL FUMARATE 2.5 mg/1 | Tablet Oral |
Unichem Pharmaceuticals (USA), Inc. | Rx |
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- NDC code
- 29300-187-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0301-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Hydrochlorothiazide recalls
See all
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Triamterene and Hydrochlorothiazide Capsules
Failed Impurity/Degradation Specifications
Other recalls by Unichem Pharmaceuticals USA Inc.
All 2026 recalls
Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Class III · Low risk
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class I · High risk
Cyclobenzaprine Hydrochloride Tablets
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Class III · Low risk
Clonidine Hydrochloride Tablets
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
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