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Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc Recalls

All product recalls associated with Zydus Pharmaceuticals (USA) Inc.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

Most Recent

Jan 2026

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 3361–3380 of 25002 recalls

Oxybutynin Chloride 15mg Tablets (Zydus) – Dissolution Failure (2023)

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Class IIModerate

FDAOct 19, 2023Nationwide• Zydus Pharmaceuticals (USA) Inc

Oxybutynin Chloride 5mg Tablets (Zydus) – Dissolution Failure (2023)

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Class IIModerate

FDAOct 19, 2023Nationwide• Zydus Pharmaceuticals (USA) Inc

Midazolam Injection (Exela Pharma) – Particulate Problem (2023)

Presence of Particulate Matter: Silicone

1...167 168169170 171...1251

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Class IHigh

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Presence of Particulate Matter: Silicone

Class IHigh

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Presence of Particulate Matter: Silicone

Class IHigh

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sucralfate Oral Suspension (VistaPharm) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

Class IHigh

FDAOct 18, 2023Nationwide• VistaPharm LLC

Alfa Romeo Tonale (Alfa Romeo) – pedestrian alert issue (2023)

Chrysler (FCA US, LLC) is recalling certain 2023-2024 Dodge Hornet and Alfa Romeo Tonale Plug-In Hybrid vehicles. The pedestrian alert siren may be missing or disconnected and fail to alert pedestrians when the vehicle is in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 141, "Minimum Sound Requirements for Hybrid and Electric Vehicles."

High

NHTSAOct 17, 2023Nationwide• ALFA ROMEO

Aminocaproic Acid Solution (VistaPharm) – High Ethylene Glycol (2023)

Failed Excipient Specifications: high content of ethylene glycol (EG)

Class IIILow

FDAOct 17, 2023Nationwide• VistaPharm LLC

PCF-H190DL Colonovideoscope (Aizu Olympus) – repair defect (2023)

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

High

FDAOct 16, 2023FL, KY, MA +3 more• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

Undeclared Yellow #5, Yellow #6, and Red #40

Class IIModerate

FDAOct 16, 2023FL• La Michoacana 100% Natural Inc

MPV Circuit Kit (Breas Medical) – ventilation risk (2023)

Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation

High

FDAOct 13, 2023Nationwide• Breas Medical, Inc.

Arcimoto FUV (Arcimoto) – tie rod assembly risk (2023)

Arcimoto Inc. (Arcimoto) is recalling certain 2023 FUV and MUV hybrid electric motorcycles. There may be insufficient thread engagement between the inner and outer tie rods, possibly resulting in the separation of the tie rod assembly.

High

NHTSAOct 13, 2023Nationwide• ARCIMOTO

BALLARD Closed Suction System (Avanos) – DEHP labeling error (2023)

Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

Moderate

FDAOct 13, 2023Nationwide• Avanos Medical, Inc.

Crystal Clear Sodium Hydroxide (Family Health) – Child Safety Issue (2023)

Fire/Burn Risk

This recall involves Family Health Products Crystal Clear Sodium Hydroxide products. Sodium hydroxide is commonly used for soapmaking and cleaning. The sodium hydroxide, also called lye or caustic soda, was sold in a resealable two-pound bag with "CRYSTAL CLEAR", "SODIUM HYDROXIDE", "Protect, Deliver, Clean", and "NaOH" printed in large type.

Moderate

CPSCOct 12, 2023Nationwide• Family Health Products Inc., Omaha, Nebraska

Cardiohelp-i System (Maquet) – weld defect (2023)

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

High

FDAOct 12, 2023Nationwide• Maquet Medical Systems USA

EVIS EXERA II Bronchovideoscope (Olympus) – combustion risk (2023)

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

High

FDAOct 12, 2023Nationwide• Olympus Corporation of the Americas

Stay Informed

Zydus Pharmaceuticals (USA) Inc Recalls

Recall Summary

Oxybutynin Chloride 15mg Tablets (Zydus) – Dissolution Failure (2023)

Oxybutynin Chloride 5mg Tablets (Zydus) – Dissolution Failure (2023)

Midazolam Injection (Exela Pharma) – Particulate Problem (2023)

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Sucralfate Oral Suspension (VistaPharm) – Microbial Contamination (2023)

Alfa Romeo Tonale (Alfa Romeo) – pedestrian alert issue (2023)

Aminocaproic Acid Solution (VistaPharm) – High Ethylene Glycol (2023)

PCF-H190DL Colonovideoscope (Aizu Olympus) – repair defect (2023)

PCF-H190L Colonovideoscope (Aizu Olympus) – repair defect (2023)

GIF-HQ190 Videoscope (Aizu Olympus) – repair defect (2023)

GIF-H190 Videoscope (Aizu Olympus) – repair defect (2023)

CF-HQ190L Colonovideoscope (Aizu Olympus) – repair defect (2023)

Ice Cream Bar Michoacana (La Michoacana) – Undeclared Dyes (2023)

MPV Circuit Kit (Breas Medical) – ventilation risk (2023)

Arcimoto FUV (Arcimoto) – tie rod assembly risk (2023)

BALLARD Closed Suction System (Avanos) – DEHP labeling error (2023)

Crystal Clear Sodium Hydroxide (Family Health) – Child Safety Issue (2023)

Cardiohelp-i System (Maquet) – weld defect (2023)

EVIS EXERA II Bronchovideoscope (Olympus) – combustion risk (2023)