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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 5,881–5,900 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21

by Ecolab Inc

Reason
Discoloration and Presence of Foreign Substance
Recall initiated
July 30, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05

by Fresenius Kabi USA, LLC

Reason
Cross Contamination with other products: trace amounts of lidocaine
Recall initiated
July 22, 2020
Reported by FDA
September 2, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.

by Aurobindo Pharma USA Inc.

Reason
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Recall initiated
August 10, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass I

Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0

by Medichem S.A.

Reason
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Recall initiated
June 24, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.

by Hikma Pharmaceuticals USA Inc.

Reason
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Recall initiated
August 14, 2020
Reported by FDA
September 2, 2020
Distribution
Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01

by Calvin Scott & Company, Inc.

Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recall initiated
July 27, 2020
Reported by FDA
August 26, 2020
Distribution
Nationwide within the United States

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.