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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

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.
Recall initiated: June 17, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.
Recall initiated: June 17, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Recall initiated: July 3, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide, Puerto Rico, and Guam.

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Drug Recall Terminated Historical recordClass II

Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA

by Axcentria Pharmaceuticals, LLC

Reason: Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Recall initiated: May 5, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

by Hospira Inc.

Reason: Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Recall initiated: June 27, 2014
Reported by FDA: July 23, 2014
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.

by Poly Pharmaceuticals, Inc

Reason: Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Recall initiated: June 26, 2014
Reported by FDA: July 23, 2014
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.

by Poly Pharmaceuticals, Inc

Reason: Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Recall initiated: June 26, 2014
Reported by FDA: July 23, 2014
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

by Teva Pharmaceuticals USA

Reason: Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Recall initiated: May 29, 2014
Reported by FDA: July 16, 2014
Distribution: Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands

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Drug Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10

by Fresenius Kabi USA, LLC

Reason: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Recall initiated: May 2, 2014
Reported by FDA: July 16, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02

by Fresenius Kabi USA, LLC

Reason: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Recall initiated: May 2, 2014
Reported by FDA: July 16, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

by Boehringer Ingelheim Roxane Inc

Reason: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Recall initiated: May 1, 2014
Reported by FDA: July 16, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

by Ferring Pharmaceuticals Inc

Reason: Discoloration; due to prolonged heat exposure.
Recall initiated: September 19, 2013
Reported by FDA: July 16, 2014
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62

by Hospira Inc.

Reason: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Recall initiated: June 6, 2014
Reported by FDA: July 16, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

by Hospira Inc.

Reason: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Recall initiated: May 16, 2014
Reported by FDA: July 16, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709

by United Therapeutics Corp.

Reason: Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Recall initiated: March 28, 2014
Reported by FDA: July 16, 2014
Distribution: Fl, TX.

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Drug Recall Terminated Historical recordClass II

BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.

by Healix Infusion Therapy, Inc.

Reason: Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
Recall initiated: February 13, 2014
Reported by FDA: July 16, 2014
Distribution: Texas

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Drug Recall Terminated Historical recordClass II

HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

by Brookfield Prescription Center Inc. dba MD Custom Rx

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Recall initiated: May 30, 2014
Reported by FDA: July 9, 2014
Distribution: WI only

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Drug Recall Terminated Historical recordClass II

HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

by Brookfield Prescription Center Inc. dba MD Custom Rx

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Recall initiated: May 30, 2014
Reported by FDA: July 9, 2014
Distribution: WI only

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Drug Recall Terminated Historical recordClass II

HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

by Brookfield Prescription Center Inc. dba MD Custom Rx

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Recall initiated: May 30, 2014
Reported by FDA: July 9, 2014
Distribution: WI only

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Drug Recall Terminated Historical recordClass II

HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

by Brookfield Prescription Center Inc. dba MD Custom Rx

Reason: Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Recall initiated: May 30, 2014
Reported by FDA: July 9, 2014
Distribution: WI only

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Data last updated: October 1, 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.