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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

PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.

by Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Reason: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Recall initiated: July 1, 2025
Reported by FDA: July 23, 2025
Distribution: CA

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Drug Recall Ongoing Historical recordClass II

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10

by Dr. Reddy's Laboratories, Inc.

Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Recall initiated: June 30, 2025
Reported by FDA: July 23, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15

by ACCORD HEALTHCARE, INC.

Reason: Subpotent Drug: Assay below the approved specification
Recall initiated: June 20, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

by Qualgen, LLC

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Recall initiated: June 16, 2025
Reported by FDA: July 23, 2025
Distribution: Nationwide within the United States.

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Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Recall initiated: June 16, 2025
Reported by FDA: July 23, 2025
Distribution: Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

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Drug Recall Ongoing Historical recordClass II

In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1

by KABANA SKIN CARE

Reason: cGMP deviations
Recall initiated: March 12, 2025
Reported by FDA: July 16, 2025
Distribution: NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1

by KABANA SKIN CARE

Reason: cGMP deviations
Recall initiated: March 12, 2025
Reported by FDA: July 16, 2025
Distribution: NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1

by KABANA SKIN CARE

Reason: cGMP deviations
Recall initiated: March 12, 2025
Reported by FDA: July 16, 2025
Distribution: NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.

by KABANA SKIN CARE

Reason: cGMP deviations
Recall initiated: March 12, 2025
Reported by FDA: July 16, 2025
Distribution: NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated: June 30, 2025
Reported by FDA: July 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass III

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.

by Macleods Pharmaceuticals Ltd

Reason: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Recall initiated: June 11, 2025
Reported by FDA: July 16, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass I

Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.

by Sandoz Inc

Reason: Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Recall initiated: June 27, 2025
Reported by FDA: July 9, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).

by Sandoz Inc

Reason: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Recall initiated: June 27, 2025
Reported by FDA: July 9, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

by AvKARE

Reason: Failed Impurity/Degradation Specifications
Recall initiated: June 26, 2025
Reported by FDA: July 9, 2025
Distribution: Nationwide in the USA

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Data last updated: October 30, 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.