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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 15,261–15,280 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05

by Blu Pharmaceuticals Inc

Reason
Defective container: Product distributed without inner seal on bottles.
Recall initiated
March 13, 2014
Reported by FDA
May 14, 2014
Distribution
NJ, UT, IL and CT

View recall →

Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.

by Wockhardt Usa Inc.

Reason
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Recall initiated
April 1, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Recall initiated
March 20, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.

by P&L Developments, LLC

Reason
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Recall initiated
April 15, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide in US

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Drug Recall Terminated Historical recordClass III

Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Recall initiated
April 9, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Recall initiated
April 9, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2.

by AbbVie Inc

Reason
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Recall initiated
March 10, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7.

by AbbVie Inc

Reason
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Recall initiated
March 10, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3779-03, UPC 3 00743 77903 5.

by AbbVie Inc

Reason
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Recall initiated
March 10, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2.

by AbbVie Inc

Reason
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Recall initiated
March 10, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9.

by AbbVie Inc

Reason
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Recall initiated
March 10, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.

by Aaron Industries Inc

Reason
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Recall initiated
April 11, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2

by Genesis Pharmaceutical, Inc.

Reason
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Recall initiated
April 1, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Recall initiated
March 20, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Recall initiated
March 20, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Recall initiated
April 21, 2014
Reported by FDA
May 7, 2014
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.

by Teva Pharmaceuticals USA

Reason
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Recall initiated
February 12, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.

by Teva Pharmaceuticals USA

Reason
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Recall initiated
February 12, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.

by Legacy Pharmaceutical Packaging

Reason
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Recall initiated
February 14, 2014
Reported by FDA
May 7, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.

by Hospira Inc.

Reason
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Recall initiated
December 23, 2013
Reported by FDA
May 7, 2014
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.