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Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Recalls

All product recalls associated with Mylan Institutional, Inc. (d.b.a. UDL Laboratories).

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Recall Summary

Total Recalls

1000

Past Year

557

Class I (Serious)

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 5581–5600 of 7756 recalls

Amlodipine Tablets 5mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Omeprazole Capsules (Kremers) – Acid Resistance Issue (2013)

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Class IIModerate

FDASep 16, 2013KY, TN• Kremers Urban Pharmaceuticals, Inc.

Oxycodone Acetaminophen Tablets (Watson) – Foreign Tablets (2013)

Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

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Class IIModerate

FDASep 13, 2013Nationwide• Watson Laboratories Inc

Motorcycle Training Wheels (Cambridge) – Crash Hazard (2013)

The recalled products are Moose Racing brand training wheels for youth motorcycles and the replacement wheel kit. The training wheels have a black, one-piece, full-length metal axle with a plate that attaches to the underside of the motorcycle frame beneath the engine and two inflatable rubber wheels. The Moose Racing logo appears on the left and right sides of the axle. The replacement wheel kit is a set of two tires mounted on the wheel assembly. Replacement wheel kits and training wheels that fit the following youth motorcycle models are being recalled: Honda XR/CRF 50, Kawasaki KDX/Suzuki JR 50, KTM 50, Suzuki DRZ 70, Yamaha PW50 and Yamaha TTR 50.

CPSCSep 11, 2013Nationwide• Cambridge Metals & Plastics, a Division of Water Works Manufacturing Inc., of Cambridge, Minn.

HCG Premium Drops (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims: "drops the fat, expels toxins, break down fat, block carbohydrates, suppresses appetite, suppresses fat absorption, creates a balance in the thyroid". In addition, the firm's website claimed to repair body tissue, such as minor ulcers and to contain anti-cancer compounds.

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

Moringa Premium Capsules (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims in the firm's website: "prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc."

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

HCG Premium Energy Drops (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims in the firm's website: "prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc."

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

HCG Premium Cleanse Drops (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims in the firm's website: "prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc."

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

Bocadin Chocolate Wafers (Mi Costenita) – Milk Allergen (2013)

Undeclared Allergen

Undeclared Allergens (Milk): Mi Costenita BOCADIN wafer with chocolate contains undeclared milk allergens.

Class IHigh

FDASep 5, 2013Nationwide• Yoli, Inc. dba Mi Costenita

Hydrocodone Acetaminophen Tablets (Watson) – Defective Container (2013)

Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Class IIILow

FDAAug 30, 2013Nationwide• Watson Laboratories Inc

Cubicin Injection (Cubist) – Glass Particulates (2013)

Presence of Particulate Matter; Glass particulates observed in vials

Class IHigh

FDAAug 29, 2013Nationwide• Cubist Pharmaceuticals, Inc.

Ibuprofen Tablets (Dr. Reddy's) – Incorrect Expiration (2013)

Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Class IIModerate

FDAAug 29, 2013Nationwide• Dr. Reddy's Laboratories, Inc.

Black & White Cookies (Irene's Bakery) – milk allergen (2013)

Undeclared Allergen

Undeclared whey powder (milk allergen) sub-ingredient of chocolate confectionery coating used in manufacturing of Black & White Cookies.

Class IHigh

FDAAug 26, 2013Nationwide• Irene's Bakery & Gourmet Kitchen, Inc.

Zim Zam Dark Chocolate Orange (G. Debbas) – Allergic Reaction (2013)

Two consumer complaints of allergic reactions for Zim Zam products packed in a picnic type lunch that declares it is vegan. G. Debbas Chocolatier does not claim that their product facility is vegan, as they do make product that contain milk.

Class IHigh

FDAAug 19, 2013IL, IN• G. Debbas Chocolatier, Inc.

Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil

Class IHigh

FDAAug 14, 2013CA, FL, UT• Fabscout Entertainment, Inc

Evil Root Supplement (Fabscout) – Undeclared Sildenafil (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil

Class IHigh

FDAAug 14, 2013CA, FL, UT• Fabscout Entertainment, Inc

Pro Power Max Energy Enhancer (Fabscout) – Undeclared Drugs (2013)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil

Class IHigh

FDAAug 14, 2013CA, FL, UT• Fabscout Entertainment, Inc

Bethel Advance (Bethel) – Unauthorized Drug Ingredients (2013)

Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.

Class IHigh

FDAAug 5, 2013Nationwide• Bethel Nutritional Consulting, Inc

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Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Recalls

Recall Summary

Amlodipine Tablets 5mg (Mylan) – Manufacturing Deviation (2013)

Omeprazole Capsules (Kremers) – Acid Resistance Issue (2013)

Oxycodone Acetaminophen Tablets (Watson) – Foreign Tablets (2013)

Motorcycle Training Wheels (Cambridge) – Crash Hazard (2013)

HCG Premium Drops (Borinquen) – Unverified Claims (2013)

Moringa Premium Capsules (Borinquen) – Unverified Claims (2013)

HCG Premium Energy Drops (Borinquen) – Unverified Claims (2013)

HCG Premium Cleanse Drops (Borinquen) – Unverified Claims (2013)

Bocadin Chocolate Wafers (Mi Costenita) – Milk Allergen (2013)

Hydrocodone Acetaminophen Tablets (Watson) – Defective Container (2013)

Cubicin Injection (Cubist) – Glass Particulates (2013)

Ibuprofen Tablets (Dr. Reddy's) – Incorrect Expiration (2013)

Black & White Cookies (Irene's Bakery) – milk allergen (2013)

Zim Zam Dark Chocolate Orange (G. Debbas) – Allergic Reaction (2013)

Zim Zam Dark Chocolate Rice Crisps (G. Debbas) – Allergic Reaction (2013)

Zim Zam Dark Chocolate Sea Salt (G. Debbas) – Allergic Reaction (2013)

72HP Male Enhancement (Fabscout) – Undeclared Sildenafil (2013)

Evil Root Supplement (Fabscout) – Undeclared Sildenafil (2013)

Pro Power Max Energy Enhancer (Fabscout) – Undeclared Drugs (2013)

Bethel Advance (Bethel) – Unauthorized Drug Ingredients (2013)