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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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Showing 5,861–5,880 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass I

bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5

by AAA Cosmetica, SA de CV

Reason
Chemical Contamination: Product contains methanol.
Recall initiated
July 2, 2020
Reported by FDA
September 9, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5

by AAA Cosmetica, SA de CV

Reason
CGMP Deviations
Recall initiated
July 2, 2020
Reported by FDA
September 9, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery

by Leiper's Fork Distillery

Reason
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Recall initiated
August 3, 2020
Reported by FDA
September 9, 2020
Distribution
TN

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Drug Recall Terminated Historical recordClass II

Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7

by Soluciones Cosmeticas, SA de CV

Reason
cGMP Deviations
Recall initiated
July 14, 2020
Reported by FDA
September 9, 2020
Distribution
United States

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Drug Recall Terminated Historical recordClass II

Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2

by ROQUE PLAST, S.A. DE C.V.

Reason
CGMP Deviation: Potential contamination with undeclared methanol.
Recall initiated
August 4, 2020
Reported by FDA
September 9, 2020
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass II

HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1

by Grato Holdings, Inc.

Reason
Labeling: Error on Declared Strength
Recall initiated
July 16, 2020
Reported by FDA
September 9, 2020
Distribution
One direct account in UT

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Drug Recall Terminated Historical recordClass II

UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220

by Santa Cruz Biotechnology, Inc

Reason
Subpotent drug
Recall initiated
August 7, 2020
Reported by FDA
September 9, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.

by Laboratorios Jaloma S.A. de C.V.

Reason
cGMP deviations
Recall initiated
July 31, 2020
Reported by FDA
September 9, 2020
Distribution
Nationwide United States and Canada.

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Drug Recall Terminated Historical recordClass I

Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.

by SCA Pharmaceuticals

Reason
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Recall initiated
July 29, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide within the U.S.

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Drug Recall Terminated Historical recordClass I

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.

by SCA Pharmaceuticals

Reason
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Recall initiated
July 29, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Terminated Historical recordClass I

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.

by SCA Pharmaceuticals

Reason
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Recall initiated
July 29, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Terminated Historical recordClass I

Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.

by SCA Pharmaceuticals

Reason
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Recall initiated
July 29, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Completed Historical recordClass II

HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013

by RESOURCE RECOVERY & TRADING LLC

Reason
cGMP deviations
Recall initiated
July 27, 2020
Reported by FDA
September 2, 2020
Distribution
AL, GA

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Drug Recall Completed Historical recordClass II

Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020

by RESOURCE RECOVERY & TRADING LLC

Reason
cGMP deviations
Recall initiated
July 27, 2020
Reported by FDA
September 2, 2020
Distribution
AL, GA

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

by Hetero Labs Limited (Unit V)

Reason
Failed Tablet/Capsule Specification; complaint of bulging tablet
Recall initiated
August 6, 2020
Reported by FDA
September 2, 2020
Distribution
Product was distributed to major wholesalers/distributors throughout the United States.

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Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01

by BAYSHORE PHARMACEUTICALS

Reason
CGMP Deviations
Recall initiated
August 19, 2020
Reported by FDA
September 2, 2020
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10

by BAYSHORE PHARMACEUTICALS

Reason
CGMP Deviations
Recall initiated
August 19, 2020
Reported by FDA
September 2, 2020
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

by Par Pharmaceutical Inc.

Reason
Failed Impurity /Degradation Specifications
Recall initiated
August 10, 2020
Reported by FDA
September 2, 2020
Distribution
Product was distributed to 9 major distributors throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass III

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

by The Mentholatum Company

Reason
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Recall initiated
July 31, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3

by Yusef Manufacturing Laboratories, LLC

Reason
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Recall initiated
June 3, 2020
Reported by FDA
September 2, 2020
Distribution
Shipped to one distributer located in Colorado

View recall →

Data last updated:

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.