Unichem Pharmaceuticals USA Inc. recalls
Every recall we track for Unichem Pharmaceuticals USA Inc. — 12 in all, from 2015–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
10 recalls since 2017.
All FDA recall records for Unichem Pharmaceuticals USA Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 1 | 2 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 2 | 2 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 1 | 1 | 1 | 3 |
Unichem Pharmaceuticals USA Inc. recalls before 2017
Recalls on record by year.
What to do if you have a recalled Unichem Pharmaceuticals USA Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Unichem Pharmaceuticals USA Inc. recalls
12 shown- Lower riskDrug
Unichem Pharmaceuticals USA Inc. recalls busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind,
Unichem Pharmaceuticals recalls 500-count busPIRone Hydrochloride Tablets (5mg) due to subpotent drug content. This may result in ineffective treatment for patients requiring precise dosing. No remedy specified in official notice.
Unichem PharmaceuticalsApr 13, 2026 - Use cautionDrug
Unichem Pharmaceuticals USA Inc. recalls Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1
Unichem Pharmaceuticals recalls 60,000 bottles of Doxazosin Tablets USP 4 mg because tablets are imprinted with the wrong identification code.
Unichem PharmaceuticalsJan 21, 2026 - UnratedDrug
Unichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by:
Unichem Pharmaceuticals USA recalls 2.5mg/6.25mg Bisoprolol Fumarate and Hydrochlorothiazide tablets due to N-Nitroso Bisoprolol impurity exceeding safety limits. Affected products were manufactured in India and shipped to US. Consumers should contact pharmacy for replacement.
UnichemJan 21, 2026 - Lower riskDrug
Unichem Pharmaceuticals USA Inc. recalls Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories,
Unichem Pharmaceuticals USA recalls 10mg Cyclobenzaprine tablets due to mislabeled with Meloxicam. Affected products have yellow bottles labeled as blue. Contact for details.
UnichemAug 27, 2025 - Lower riskDrug
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD.
Unichem Pharmaceuticals USA recalls 0.3mg Clonidine Hydrochloride Tablets due to possible mix-up with 0.2mg strength. This could lead to incorrect dosing if used without medical supervision.
Unichem PharmaceuticalsSep 19, 2022 - Lower riskDrug
UNICHEM PHARMACEUTICALS USA INC recalls Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut
Unichem Pharmaceuticals USA recalls 50mg Topiramate tablets due to discoloration. This may affect safety but does not indicate immediate risk. Check NDC 29300-116-05 for affected lots.
Unichem PharmaceuticalsOct 25, 2021 - UnratedDrug
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD.
Unichem Pharmaceuticals USA recalls 0.1 mg clonidine tablets due to potential benzophenone migration from containers. These prescription-only tablets were manufactured in India and distributed in the US. Consumers should contact the company for details.
Unichem PharmaceuticalsMay 26, 2020 - UnratedDrug
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd.
Unichem recalls 19,161,600 bottles of Clonidine Hydrochloride 0.1mg tablets due to potential Benzophenone migration from container labels.
Unichem PharmaceuticalsJan 29, 2020 - Lower riskDrug
Unichem Pharmaceuticals Usa Inc recalls Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories
Unichem Pharmaceuticals recalls 500mg Divalproex Sodium tablets due to metronidazole powder cross contamination. This could cause unintended medication interactions. Return to Unichem for replacement.
UnichemDec 19, 2017 - UnratedDrug
Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.
Unichem Pharmaceuticals recalls 5mg Bisoprolol Fumarate tablets due to potential impurity during stability testing. Affected lots manufactured in India, expiring 2017-2018. No specific remedy provided in recall notice.
UnichemOct 2, 2017 - Lower riskDrug
Unichem Pharmaceuticals Usa Inc recalls Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD.,
Unichem Pharmaceuticals recalls 150mg Lamotrigine tablets with incorrect imprint debossed on the tablets. This could lead to confusion with other medications. Contact Unichem for details.
UnichemAug 19, 2016 - Stop using nowDrug
Unichem Pharmaceuticals Usa Inc recalls Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne
Unichem recalls 1000-count bottles of Hydrochlorothiazide 25 mg tablets due to a foreign clopidogrel tablet found inside. Check your lot number.
Unichem PharmaceuticalsJul 30, 2015
Unichem Pharmaceuticals USA Inc. recall questions
How many recalls has Unichem Pharmaceuticals USA Inc. had?
12 recalls from Unichem Pharmaceuticals USA Inc. are on record with U.S. safety agencies, from 2015–2026.
What is the most recent Unichem Pharmaceuticals USA Inc. recall?
Unichem Pharmaceuticals USA Inc. recalls busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind,, dated Apr 13, 2026. Every Unichem Pharmaceuticals USA Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Unichem Pharmaceuticals USA Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Unichem Pharmaceuticals USA Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.