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Caraco Pharmaceutical Laboratories, Ltd.

Caraco Pharmaceutical Laboratories, Ltd. Recalls

All product recalls associated with Caraco Pharmaceutical Laboratories, Ltd..

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Recall Summary

Total Recalls

1000

Past Year

304

Class I (Serious)

Most Recent

Nov 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 3901–3920 of 4747 recalls

Cetirizine Chewables (Caraco) – impurity concern (2014)

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Class IIILow

FDAApr 9, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Pantoprazole Sodium Tablets (Legacy) – packaging error (2014)

Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets

Class IIModerate

FDAApr 9, 2014IN• Legacy Pharmaceutical Packaging

Buprenorphine Sublingual Tablets (Teva) – impurity problem (2014)

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

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Class IIModerate

FDAApr 7, 2014Nationwide• Teva Pharmaceuticals USA

Buprenorphine Sublingual Tablets (Teva) – impurity issue (2014)

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

Class IIModerate

FDAApr 7, 2014Nationwide• Teva Pharmaceuticals USA

Sevoflurane Anesthetic (Piramal) – pH specification failure (2014)

Failed pH Specifications: product was too acidic.

Class IIModerate

FDAApr 7, 2014Nationwide• Piramal Critical Care, Inc.

Psyllium Fiber Supplement (Konsyl) – strength labeling error (2014)

Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.

Class IIILow

FDAApr 1, 2014FL, MN, NY +6 more• Konsyl Pharmaceuticals Inc

Glytone Acne Cleanser (Genesis) – viscosity issue (2014)

Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.

Class IIILow

FDAApr 1, 2014Nationwide• Genesis Pharmaceutical, Inc.

Lansoprazole Triple Therapy (Teva) – impurity concern (2014)

Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

Class IIModerate

FDAApr 1, 2014Nationwide• Teva Pharmaceuticals USA

Tyvaso (United Therapeutics) – Defective Delivery System (2014)

Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

Class IIModerate

FDAMar 28, 2014FL, TX• United Therapeutics Corp.