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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 Ongoing Historical recordClass II

Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

by Golden State Medical Supply Inc.

Reason: CGMP Deviations
Recall initiated: March 16, 2022
Reported by FDA: July 13, 2022
Distribution: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI

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Drug Recall Ongoing Historical recordClass II

Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

by Golden State Medical Supply Inc.

Reason: CGMP Deviations
Recall initiated: March 16, 2022
Reported by FDA: July 13, 2022
Distribution: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI

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Drug Recall Ongoing Historical recordClass II

Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

by Golden State Medical Supply Inc.

Reason: CGMP Deviations
Recall initiated: March 16, 2022
Reported by FDA: July 13, 2022
Distribution: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI

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Drug Recall Ongoing Historical recordClass II

Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.

by Golden State Medical Supply Inc.

Reason: CGMP Deviations
Recall initiated: March 16, 2022
Reported by FDA: July 13, 2022
Distribution: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Recall initiated: June 3, 2022
Reported by FDA: July 13, 2022
Distribution: nationwide.

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Drug Recall Terminated Historical recordClass I

CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2.

by Vi-Jon, LLC

Reason: Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Recall initiated: June 13, 2022
Reported by FDA: July 13, 2022
Distribution: Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07

by Macleods Pharma Usa Inc

Reason: Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Recall initiated: June 16, 2022
Reported by FDA: July 13, 2022
Distribution: Distributed Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: Defective Container
Recall initiated: June 16, 2022
Reported by FDA: July 13, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16

by Akorn, Inc.

Reason: Defective container: defect prevents product from dispensing as intended.
Recall initiated: June 13, 2022
Reported by FDA: July 6, 2022
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: June 29, 2022
Reported by FDA: July 6, 2022
Distribution: One sole distributor in TX

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Drug Recall Terminated Historical recordClass II

Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02

by Akorn, Inc.

Reason: Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Recall initiated: June 10, 2022
Reported by FDA: July 6, 2022
Distribution: Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Recall initiated: June 24, 2022
Reported by FDA: July 6, 2022
Distribution: Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01

by Akcea Therapeutics, Inc.

Reason: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Recall initiated: May 23, 2022
Reported by FDA: July 6, 2022
Distribution: KY, USA

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Drug Recall Terminated Historical recordClass I

SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3

by Green Pharmaceuticals, Inc.

Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Recall initiated: June 9, 2022
Reported by FDA: July 6, 2022
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated: June 10, 2022
Reported by FDA: July 6, 2022
Distribution: Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated: June 6, 2022
Reported by FDA: July 6, 2022
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated: June 6, 2022
Reported by FDA: July 6, 2022
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated: June 6, 2022
Reported by FDA: July 6, 2022
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass I

Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116

by Buzzagogo, LLC

Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
Recall initiated: June 8, 2022
Reported by FDA: July 6, 2022
Distribution: Product was distributed via the internet to consumers, retailers and to distributors who may have further distributed the product.

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Drug Recall Terminated Historical recordClass II

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

by Teva Pharmaceuticals USA Inc

Reason: Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Recall initiated: June 14, 2022
Reported by FDA: June 29, 2022
Distribution: Nationwide in the U.S.

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Data last updated: September 12, 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.