Unichem Pharmaceuticals USA Inc. Recalls

All product recalls associated with Unichem Pharmaceuticals USA Inc..

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Recall Summary

Total Recalls

9

Past Year

1

Class I (Serious)

1

Most Recent

Aug 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

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 IHigh

FDAAug 27, 2025Nationwide• Unichem Pharmaceuticals USA Inc.

Clonidine Hydrochloride Tablets (UNICHEM) – Product Mix-up (2022)

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Class IIILow

FDASep 19, 2022Nationwide• UNICHEM PHARMACEUTICALS USA INC

Topiramate Tablets (Unichem) – Tablet Discoloration (2021)

Discoloration

Class III

Low

FDAOct 25, 2021Nationwide• UNICHEM PHARMACEUTICALS USA INC

Clonidine Hydrochloride Tablets (Unichem) – Benzophenone Migration (2020)

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

Class IIILow

FDAMay 26, 2020Nationwide• UNICHEM PHARMACEUTICALS USA INC

Clonidine Tablets (Unichem) – Benzophenone Migration (2020)

Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.

Class IIILow

FDAJan 29, 2020Nationwide• UNICHEM PHARMACEUTICALS USA INC

Divalproex Sodium Tablets (Unichem Pharmaceuticals) – Cross Contamination (2017)

Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

Class IIModerate

FDADec 19, 2017Nationwide• Unichem Pharmaceuticals Usa Inc

Bisoprolol Fumarate Tablets 5mg (Unichem) – impurity issue (2017)

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Class IIModerate

FDAOct 2, 2017Nationwide• Unichem Pharmaceuticals Usa Inc

Lamotrigine Tablets (Unichem) – Incorrect Tablet Imprint (2016)

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

Class IIILow

FDAAug 19, 2016Nationwide• Unichem Pharmaceuticals Usa Inc

Hydrochlorothiazide Tablets (Unichem) – Tablet Contamination (2015)

Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

Class IIModerate

FDAJul 30, 2015Nationwide• Unichem Pharmaceuticals Usa Inc

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Unichem Pharmaceuticals USA Inc. Recalls

Recall Summary

Cyclobenzaprine Tablets (Unichem) – Labeling Mix-Up (2025)

Clonidine Hydrochloride Tablets (UNICHEM) – Product Mix-up (2022)

Topiramate Tablets (Unichem) – Tablet Discoloration (2021)

Clonidine Hydrochloride Tablets (Unichem) – Benzophenone Migration (2020)

Clonidine Tablets (Unichem) – Benzophenone Migration (2020)

Divalproex Sodium Tablets (Unichem Pharmaceuticals) – Cross Contamination (2017)

Bisoprolol Fumarate Tablets 5mg (Unichem) – impurity issue (2017)

Lamotrigine Tablets (Unichem) – Incorrect Tablet Imprint (2016)

Hydrochlorothiazide Tablets (Unichem) – Tablet Contamination (2015)