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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 9,561–9,580 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4

by Apotex Inc.

Reason
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Recall initiated
May 8, 2018
Reported by FDA
May 23, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4

by Apotex Inc.

Reason
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Recall initiated
May 8, 2018
Reported by FDA
May 23, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

by Mylan Pharmaceuticals Inc.

Reason
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
Product was distributed throughout United States

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Drug Recall Terminated Historical recordClass II

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

by Mylan Pharmaceuticals Inc.

Reason
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
Product was distributed throughout United States

View recall →

Drug Recall Terminated Historical recordClass III

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

by Sun Pharmaceutical Industries, Inc.

Reason
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Recall initiated
April 26, 2018
Reported by FDA
May 23, 2018
Distribution
US Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02

by Perrigo New York

Reason
Failed Stability Specifications
Recall initiated
May 7, 2018
Reported by FDA
May 23, 2018
Distribution
US Nationwide including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010

by L. Perrigo Company

Reason
Defective delivery system
Recall initiated
May 11, 2018
Reported by FDA
May 23, 2018
Distribution
Nationwide in the U.S.A.

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Drug Recall Terminated Historical recordClass II

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

by Pharmalucence, Inc.

Reason
Failed Stability Specifications
Recall initiated
April 10, 2018
Reported by FDA
May 23, 2018
Distribution
US Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN

by Milbar Laboratories, Inc.

Reason
GMP Deviations
Recall initiated
May 4, 2018
Reported by FDA
May 23, 2018
Distribution
Within the United States and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.

by Milbar Laboratories, Inc.

Reason
GMP Deviations
Recall initiated
May 4, 2018
Reported by FDA
May 23, 2018
Distribution
Within the United States and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

by Milbar Laboratories, Inc.

Reason
GMP Deviations
Recall initiated
May 4, 2018
Reported by FDA
May 23, 2018
Distribution
Within the United States and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

by Milbar Laboratories, Inc.

Reason
Microbial Contamination of Non-sterile Product
Recall initiated
May 4, 2018
Reported by FDA
May 23, 2018
Distribution
Within the United States and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00

by Aidarex Pharmaceuticals LLC

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
April 10, 2018
Reported by FDA
May 23, 2018
Distribution
Product was distributed to Florida

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Drug Recall Terminated Historical recordClass II

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834

by Prescript Pharmaceuticals, Inc.

Reason
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
California.

View recall →

Drug Recall Terminated Historical recordClass II

Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11

by Prescript Pharmaceuticals, Inc.

Reason
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
California.

View recall →

Drug Recall Terminated Historical recordClass II

Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482

by Prescript Pharmaceuticals, Inc.

Reason
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
California.

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033

by Prescript Pharmaceuticals, Inc.

Reason
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
California.

View recall →

Drug Recall Terminated Historical recordClass II

Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176

by Prescript Pharmaceuticals, Inc.

Reason
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Recall initiated
April 24, 2018
Reported by FDA
May 23, 2018
Distribution
California.

View recall →

Drug Recall Terminated Historical recordClass III

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

by Boiron Inc.

Reason
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Recall initiated
April 13, 2018
Reported by FDA
May 23, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Recall initiated
April 19, 2018
Reported by FDA
May 23, 2018
Distribution
Nationwide in the USA

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.