Public Health Trace

Get Alerts

FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

Filters

Drug Recall Terminated Historical recordClass II

DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853

by Milbar Laboratories, Inc.

Reason: GMP Deviations
Recall initiated: October 9, 2020
Reported by FDA: November 25, 2020
Distribution: Product was distributed throughout the United States, including Puerto Rico and internationally.

View recall →

Drug Recall Terminated Historical recordClass II

DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627

by Milbar Laboratories, Inc.

Reason: GMP Deviations
Recall initiated: October 9, 2020
Reported by FDA: November 25, 2020
Distribution: Product was distributed throughout the United States, including Puerto Rico and internationally.

View recall →

Drug Recall Ongoing Historical recordClass II

NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3

by Albek De Mexico S.A. De C.V.

Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Recall initiated: July 30, 2020
Reported by FDA: November 25, 2020
Distribution: USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

by Albek De Mexico S.A. De C.V.

Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Recall initiated: July 30, 2020
Reported by FDA: November 25, 2020
Distribution: USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

by Albek De Mexico S.A. De C.V.

Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Recall initiated: July 30, 2020
Reported by FDA: November 25, 2020
Distribution: USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6

by Albek De Mexico S.A. De C.V.

Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Recall initiated: July 30, 2020
Reported by FDA: November 25, 2020
Distribution: USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5

by Albek De Mexico S.A. De C.V.

Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Recall initiated: July 30, 2020
Reported by FDA: November 25, 2020
Distribution: USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

by Preferred Pharmaceuticals, Inc.

Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall initiated: November 1, 2020
Reported by FDA: November 25, 2020
Distribution: Distributed to two physician's offices located in FL.

View recall →

Drug Recall Terminated Historical recordClass II

Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

by H & H Remedies, LLC

Reason: CGMP Deviations
Recall initiated: October 21, 2020
Reported by FDA: November 18, 2020
Distribution: Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

by Baxter Healthcare Corporation

Reason: Presence of particulate matter in solution - black and transparent particles
Recall initiated: October 7, 2020
Reported by FDA: November 18, 2020
Distribution: Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

by H & H Remedies, LLC

Reason: CGMP Deviations
Recall initiated: October 21, 2020
Reported by FDA: November 18, 2020
Distribution: Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

by H & H Remedies, LLC

Reason: CGMP Deviations
Recall initiated: October 21, 2020
Reported by FDA: November 18, 2020
Distribution: Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12

by AVKARE Inc.

Reason: Failed Dissolution Specifications
Recall initiated: October 30, 2020
Reported by FDA: November 18, 2020
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.

by Teva Pharmaceuticals USA

Reason: Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Recall initiated: October 28, 2020
Reported by FDA: November 18, 2020
Distribution: Nationwide in the U.S. and PR

View recall →

Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specification
Recall initiated: October 27, 2020
Reported by FDA: November 11, 2020
Distribution: Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specification
Recall initiated: October 27, 2020
Reported by FDA: November 11, 2020
Distribution: Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

by Nostrum Laboratories Inc

Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated: October 23, 2020
Reported by FDA: November 11, 2020
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

by Nostrum Laboratories Inc

Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated: October 23, 2020
Reported by FDA: November 11, 2020
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32

by Jubilant Cadista Pharmaceuticals, Inc.

Reason: Subpotent
Recall initiated: October 26, 2020
Reported by FDA: November 11, 2020
Distribution: Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92

by Aurobindo Pharma USA Inc.

Reason: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Recall initiated: October 22, 2020
Reported by FDA: November 11, 2020
Distribution: NJ

View recall →

Data last updated: September 15, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.