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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 13,801–13,820 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.

by West-Ward Pharmaceutical Corp.

Reason
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Recall initiated
May 13, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

by Novartis Pharmaceuticals Corp.

Reason
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Recall initiated
May 22, 2015
Reported by FDA
June 24, 2015
Distribution
NJ via 1 distributor

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Drug Recall Terminated Historical recordClass III

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

by Novartis Pharmaceuticals Corp.

Reason
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Recall initiated
May 22, 2015
Reported by FDA
June 24, 2015
Distribution
NJ via 1 distributor

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Drug Recall Terminated Historical recordClass II

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Recall initiated
May 22, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Recall initiated
May 22, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.

by Allegiant Health

Reason
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Recall initiated
May 12, 2015
Reported by FDA
June 24, 2015
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.

by SCA Pharmaceuticals

Reason
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Recall initiated
April 28, 2015
Reported by FDA
June 17, 2015
Distribution
CA

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Drug Recall Terminated Historical recordClass II

MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04

by Mallinckrodt, Inc.

Reason
Labeling: incorrect or missing lot number and/or expiration date
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
Costa Rica

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Drug Recall Terminated Historical recordClass II

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

by Baxter Healthcare Corp

Reason
Subpotent Drug; out of specification results for heparin raw material
Recall initiated
June 3, 2015
Reported by FDA
June 17, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 7, 2015
Reported by FDA
June 17, 2015
Distribution
Nationwide including Puerto Rico

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Drug Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 7, 2015
Reported by FDA
June 17, 2015
Distribution
Nationwide including Puerto Rico

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Drug Recall Terminated Historical recordClass II

Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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Drug Recall Terminated Historical recordClass II

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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Drug Recall Terminated Historical recordClass II

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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Drug Recall Terminated Historical recordClass II

Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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Drug Recall Terminated Historical recordClass II

Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

View recall →

Drug Recall Terminated Historical recordClass II

Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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Drug Recall Terminated Historical recordClass II

Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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Drug Recall Terminated Historical recordClass II

Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

View recall →

Drug Recall Terminated Historical recordClass II

Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Recall initiated
May 15, 2015
Reported by FDA
June 17, 2015
Distribution
MT and ND

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.