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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 III

Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550

by Geritrex Corp

Reason: CGMP Deviation: Poor container closure of the bulk storage container
Recall initiated: June 5, 2015
Reported by FDA: July 22, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01

by Kremers Urban Pharmaceuticals, Inc.

Reason: Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Recall initiated: July 7, 2015
Reported by FDA: July 22, 2015
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01

by Kremers Urban Pharmaceuticals, Inc.

Reason: Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Recall initiated: July 7, 2015
Reported by FDA: July 22, 2015
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.

by American Health Packaging

Reason: Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Recall initiated: June 26, 2015
Reported by FDA: July 22, 2015
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

by Fresenius Kabi USA, LLC

Reason: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Recall initiated: June 4, 2015
Reported by FDA: July 22, 2015
Distribution: Nationwide,Hawaii, and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12

by BioComp Pharma, Inc.

Reason: Subpotent Drug: menthol and methyl salicylate below specification
Recall initiated: July 6, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02

by Hospira Inc.

Reason: Failed pH Specifications: 12 month stability testing
Recall initiated: May 19, 2015
Reported by FDA: July 15, 2015
Distribution: U.S. Nationwide, Kuwait, Bahrain and Israel.

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Drug Recall Terminated Historical recordClass III

CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31

by Abrams Royal Pharmacy II, LLC

Reason: Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Recall initiated: June 23, 2015
Reported by FDA: July 15, 2015
Distribution: United States including: Texas

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Drug Recall Terminated Historical recordClass II

Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated: June 1, 2015
Reported by FDA: July 15, 2015
Distribution: Nationwide

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Data last updated: September 28, 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.