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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

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46

by Lannett Company Inc.

Reason: Failed Dissolution Specifications
Recall initiated: October 10, 2025
Reported by FDA: October 29, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25

by Church & Dwight Co., Inc.

Reason: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Recall initiated: October 1, 2025
Reported by FDA: October 29, 2025
Distribution: Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

by Graviti Pharmaceuticals Private Limited

Reason: Failed Tablet/Capsule Specifications
Recall initiated: September 15, 2025
Reported by FDA: October 29, 2025
Distribution: Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.

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Drug Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).

by Aspiro Pharma Limited

Reason: Presence of Particulate Matter: Particulate matter identified as glass
Recall initiated: October 1, 2025
Reported by FDA: October 29, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.

by Medline Industries, LP

Reason: Subpotent Drug
Recall initiated: September 29, 2025
Reported by FDA: October 29, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05

by USV Private Limited

Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Recall initiated: October 9, 2025
Reported by FDA: October 29, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50

by JB Chemicals and Pharmaceuticals Ltd

Reason: Tablet/Capsules Imprinted with Wrong ID
Recall initiated: September 12, 2025
Reported by FDA: October 29, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass III

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason: Tablet/Capsules Imprinted with Wrong ID
Recall initiated: September 12, 2025
Reported by FDA: October 29, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).

by The Harvard Drug Group LLC

Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recall initiated: October 10, 2025
Reported by FDA: October 29, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

by The Harvard Drug Group LLC

Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recall initiated: October 10, 2025
Reported by FDA: October 29, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01

by Rising Pharma Holding, Inc.

Reason: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Recall initiated: October 7, 2025
Reported by FDA: October 22, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30

by ASTRAZENECA PHARMACEUTICALS

Reason: Lack of Assurance of Sterility:
Recall initiated: October 8, 2025
Reported by FDA: October 22, 2025
Distribution: Nationwide in the U.S

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Drug Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

by Amerisource Health Services LLC

Reason: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Recall initiated: October 9, 2025
Reported by FDA: October 22, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91

by ENDO USA, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Recall initiated: September 5, 2025
Reported by FDA: October 22, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.

by STAQ Pharma, Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated: October 9, 2025
Reported by FDA: October 22, 2025
Distribution: Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass III

Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.

by STAQ Pharma, Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated: October 9, 2025
Reported by FDA: October 22, 2025
Distribution: Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass III

Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.

by STAQ Pharma, Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated: October 9, 2025
Reported by FDA: October 22, 2025
Distribution: Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass II

Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344

by SV Labs Prescott Corporation

Reason: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Recall initiated: September 25, 2025
Reported by FDA: October 22, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Impurities/Degradation Specifications
Recall initiated: September 3, 2025
Reported by FDA: October 22, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

by Ascend Laboratories, LLC

Reason: Failed Dissolution Specifications
Recall initiated: September 19, 2025
Reported by FDA: October 22, 2025
Distribution: U.S. Nationwide

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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.