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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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Drug Recall Terminated Historical recordClass II

Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.

by AtHome Medical, Inc.

Reason: GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Recall initiated: May 11, 2017
Reported by FDA: August 16, 2017
Distribution: NJ

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Drug Recall Terminated Historical recordClass II

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

by X-Gen Pharmaceuticals Inc.

Reason: Presence of Foreign Substance: potential presence of plastic particles.
Recall initiated: May 17, 2017
Reported by FDA: August 16, 2017
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15

by Teva Pharmaceuticals USA

Reason: Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Recall initiated: August 2, 2017
Reported by FDA: August 16, 2017
Distribution: Product distributed to OH, IL, PA, MI, VA and CT

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Drug Recall Terminated Historical recordClass II

Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30

by PD-Rx Pharmaceuticals, Inc.

Reason: Failed Tablet/Capsule Specification: out of specification for tablet weight.
Recall initiated: July 28, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60

by Teva Pharmaceuticals USA

Reason: Failed Tablet/Capsule Specification; out of specification for tablet weight
Recall initiated: July 24, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50

by Time-Cap Laboratories, Inc.

Reason: Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Recall initiated: June 16, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide U.S.A.

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Drug Recall Terminated Historical recordClass II

Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magnesium Citrate, UPC# 308690686383, NDC 0869-686-38, Distributed by: Vi-Jon, Smyrna, TN, 37167 ; d) ShopRite Magnesium Citrate Oral Solution Saline Laxative Low Sodium, UPC# 041190211487, NDC 41190-686-38, Distributed by: Wakefern Food Corporation, Jamesburg, NJ 08831

by Vi-Jon, Inc.

Reason: Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Recall initiated: July 17, 2017
Reported by FDA: August 9, 2017
Distribution: GA, PA, NJ

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Drug Recall Terminated Historical recordClass II

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

by VistaPharm, Inc.

Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Recall initiated: June 26, 2017
Reported by FDA: August 9, 2017
Distribution: CA, IL, LA, NH, OH, PA, SC

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Drug Recall Terminated Historical recordClass II

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

by VistaPharm, Inc.

Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Recall initiated: June 26, 2017
Reported by FDA: August 9, 2017
Distribution: CA, IL, LA, NH, OH, PA, SC

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Drug Recall Terminated Historical recordClass II

Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085

by Bayer HealthCare Pharmaceuticals, Inc.

Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Recall initiated: March 30, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048

by Bayer HealthCare Pharmaceuticals, Inc.

Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Recall initiated: March 30, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA

by Hospira a Pfizer Company

Reason: Lack of Sterility Assurance
Recall initiated: June 15, 2017
Reported by FDA: August 9, 2017
Distribution: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

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Drug Recall Terminated Historical recordClass II

Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).

by Hospira a Pfizer Company

Reason: Lack of Sterility Assurance
Recall initiated: June 15, 2017
Reported by FDA: August 9, 2017
Distribution: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

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Drug Recall Terminated Historical recordClass II

8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

by Hospira a Pfizer Company

Reason: Lack of Sterility Assurance
Recall initiated: June 15, 2017
Reported by FDA: August 9, 2017
Distribution: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

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Drug Recall Terminated Historical recordClass II

Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01

by Hospira a Pfizer Company

Reason: Lack of Sterility Assurance
Recall initiated: June 15, 2017
Reported by FDA: August 9, 2017
Distribution: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

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Drug Recall Terminated Historical recordClass II

Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194

by Bayer HealthCare Pharmaceuticals, Inc.

Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Recall initiated: March 30, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

by Zydus Pharmaceuticals USA Inc

Reason: Failed Dissolution Specifications
Recall initiated: May 10, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

by Zydus Pharmaceuticals USA Inc

Reason: Failed Dissolution Specifications
Recall initiated: May 10, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01

by Zydus Pharmaceuticals USA Inc

Reason: Failed Dissolution Specifications
Recall initiated: May 10, 2017
Reported by FDA: August 9, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason: CGMP Deviations
Recall initiated: July 12, 2017
Reported by FDA: August 9, 2017
Distribution: There were only one customer in California

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Data last updated: September 24, 2026 ET

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.