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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 10,661–10,680 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.

by Bausch & Lomb, Inc.

Reason
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Recall initiated
June 6, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

by Hospira Inc., A Pfizer Company

Reason
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Recall initiated
May 18, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide, Canada and Singapore

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Drug Recall Terminated Historical recordClass III

Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01

by Hetero USA Inc

Reason
Presence of Foreign Substance: human hair melded into tablet.
Recall initiated
April 27, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,

by Qualgen

Reason
CGMP deviations- Lack of Quality Assurance
Recall initiated
April 19, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401

by MedPark Pharmacy, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 1, 2017
Reported by FDA
June 14, 2017
Distribution
Distributed to patient in Maryland

View recall →

Drug Recall Terminated Historical recordClass II

Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12

by L. Perrigo Company

Reason
Defective Container: Carton is missing the tablet blister strip and tablet.
Recall initiated
June 1, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the US and Canada

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Drug Recall Terminated Historical recordClass II

Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Recall initiated
May 22, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Recall initiated
May 22, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Recall initiated
May 22, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Recall initiated
May 22, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.

by Spectrum Laboratory Products, Inc.

Reason
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Recall initiated
April 13, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.

by Spectrum Laboratory Products, Inc.

Reason
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Recall initiated
April 13, 2017
Reported by FDA
June 14, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06

by Forest Laboratories, LLC

Reason
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Recall initiated
May 18, 2017
Reported by FDA
June 7, 2017
Distribution
Nationwide

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.