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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.

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Drug Recall Terminated Historical recordClass II

clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30

by Jubilant Cadista Pharmaceuticals, Inc.

Reason: Failed Tablet/Capsule Specification
Recall initiated: November 6, 2020
Reported by FDA: December 2, 2020
Distribution: Product was distributed nationwide.

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Drug Recall Completed Historical recordClass I

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.

by Sunstar Americas, Inc.

Reason: Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Recall initiated: October 27, 2020
Reported by FDA: December 2, 2020
Distribution: USA Nationwide

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Drug Recall Completed Historical recordClass II

SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .

by AA PRODUCTS INC

Reason: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Recall initiated: September 24, 2020
Reported by FDA: December 2, 2020
Distribution: Texas

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Drug Recall Terminated Historical recordClass II

Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

by Apotex Corp.

Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Recall initiated: November 11, 2020
Reported by FDA: November 25, 2020
Distribution: Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.

by Hikma Pharmaceuticals USA Inc.

Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Recall initiated: November 3, 2020
Reported by FDA: November 25, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass III

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.

by Teva Pharmaceuticals USA

Reason: Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Recall initiated: November 11, 2020
Reported by FDA: November 25, 2020
Distribution: Product was distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.

by Grato Holdings, Inc.

Reason: Labeling: Product Contains Undeclared API; Incorrect formulation
Recall initiated: September 17, 2020
Reported by FDA: November 25, 2020
Distribution: UT

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Drug Recall Terminated Historical recordClass II

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01

by Ascent Pharmaceuticals, Inc.

Reason: Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Recall initiated: October 26, 2020
Reported by FDA: November 25, 2020
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics

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.

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Drug Recall Terminated Historical recordClass II

DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

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.

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Drug Recall Terminated Historical recordClass II

DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

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.

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Drug Recall Terminated Historical recordClass II

Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads

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.

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Drug Recall Terminated Historical recordClass II

Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226

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.

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Drug Recall Terminated Historical recordClass II

MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN

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.

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Drug Recall Terminated Historical recordClass II

(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

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.

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Drug Recall Terminated Historical recordClass II

(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

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.

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Drug Recall Terminated Historical recordClass II

(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

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.

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Drug Recall Terminated Historical recordClass II

DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947

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.

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Drug Recall Terminated Historical recordClass II

DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120

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.

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Drug Recall Terminated Historical recordClass II

DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471

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.

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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.