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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

Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1

by ASEGUA THERAPEUTICS LLC

Reason: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Recall initiated: March 7, 2025
Reported by FDA: April 16, 2025
Distribution: US Nationwide

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Drug Recall Ongoing Historical recordClass III

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Cross Contamination
Recall initiated: March 4, 2025
Reported by FDA: April 16, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Cross Contamination
Recall initiated: March 4, 2025
Reported by FDA: April 16, 2025
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.

by Zydus Pharmaceuticals (USA) Inc

Reason: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Recall initiated: March 21, 2025
Reported by FDA: April 16, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Recall initiated: March 11, 2025
Reported by FDA: April 9, 2025
Distribution: Nationwide in the USA and PR

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Recall initiated: March 26, 2025
Reported by FDA: April 9, 2025
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.

by Amerisource Health Services LLC

Reason: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Recall initiated: March 24, 2025
Reported by FDA: April 9, 2025
Distribution: USA nationwide.

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Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13

by BIOCON PHARMA INC

Reason: Failed dissolution specifications: lower than specifications
Recall initiated: March 17, 2025
Reported by FDA: April 9, 2025
Distribution: U.S.A. nationwide

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Drug Recall Ongoing Historical recordClass III

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

by Imprimis NJOF, LLC

Reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Recall initiated: February 24, 2025
Reported by FDA: April 9, 2025
Distribution: FL and NY

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Drug Recall Terminated Historical recordClass III

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Recall initiated: March 4, 2025
Reported by FDA: April 9, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4

by Exela Pharma Sciences LLC

Reason: Lack of Assurance of Sterility
Recall initiated: March 7, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.

by Consumer Product Partners, LLC

Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Recall initiated: March 7, 2025
Reported by FDA: April 2, 2025
Distribution: VA

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Drug Recall Ongoing Historical recordClass I

SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7

by Ascent Consumer Products Inc.

Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiated: January 28, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in the US.

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Drug Recall Ongoing Historical recordClass I

SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4

by Ascent Consumer Products Inc.

Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiated: January 28, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in the US.

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Drug Recall Ongoing Historical recordClass I

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1

by Ascent Consumer Products Inc.

Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Recall initiated: January 28, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in the US.

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Drug Recall Ongoing Historical recordClass II

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.

by Johnson, S C and Son, Inc

Reason: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Recall initiated: January 8, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75

by QuVa Pharma, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: March 6, 2025
Reported by FDA: April 2, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

by QuVa Pharma, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: March 6, 2025
Reported by FDA: April 2, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

by QuVa Pharma, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: March 6, 2025
Reported by FDA: April 2, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

by Strides Pharma, Inc.

Reason: Presence of foreign substance: Presence of Benzene.
Recall initiated: March 5, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in the U.S

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Data last updated: October 31, 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.