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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 5,521–5,540 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426

by DLC Laboratories, Inc

Reason
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Recall initiated
January 6, 2021
Reported by FDA
February 24, 2021
Distribution
Distributed Nationwide and to the following foreign countries: Canada, Cambodia, Germany, and United Kingdom.

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Drug Recall Terminated Historical recordClass I

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.; UPC # 7 501799 118981

by Liq-E S.A. De C.V.

Reason
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Recall initiated
July 20, 2020
Reported by FDA
February 24, 2021
Distribution
Distributed Nationwide in the United States and Mexico.

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Drug Recall Terminated Historical recordClass I

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477; NDC: XXXXX-378-04, UPC # 7 501799 118837

by Liq-E S.A. De C.V.

Reason
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Recall initiated
July 20, 2020
Reported by FDA
February 24, 2021
Distribution
Distributed Nationwide in the United States and Mexico.

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Drug Recall Terminated Historical recordClass I

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.UPC # 7 501799 118998

by Liq-E S.A. De C.V.

Reason
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Recall initiated
July 20, 2020
Reported by FDA
February 24, 2021
Distribution
Distributed Nationwide in the United States and Mexico.

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Drug Recall Terminated Historical recordClass I

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621

by Liq-E S.A. De C.V.

Reason
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Recall initiated
July 20, 2020
Reported by FDA
February 24, 2021
Distribution
Distributed Nationwide in the United States and Mexico.

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Drug Recall Ongoing Historical recordClass I

Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label)

by Apotex Corp.

Reason
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Recall initiated
February 2, 2021
Reported by FDA
February 17, 2021
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass I

Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)

by Apotex Corp.

Reason
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Recall initiated
February 2, 2021
Reported by FDA
February 17, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211

by Stanley Specialty Pharmacy Compounding and Wellness Center

Reason
Superpotent Drug. Lidocaine higher concentration than listed
Recall initiated
January 21, 2021
Reported by FDA
February 17, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurity/Degradation Specifications
Recall initiated
February 5, 2021
Reported by FDA
February 17, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)

by ACCORD HEALTHCARE, INC.

Reason
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Recall initiated
January 28, 2021
Reported by FDA
February 17, 2021
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

by Nostrum Laboratories Inc

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Recall initiated
January 25, 2021
Reported by FDA
February 10, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01

by AuroMedics Pharma LLC

Reason
Discoloration and failed pH specifications
Recall initiated
December 30, 2020
Reported by FDA
February 10, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Recall initiated
January 21, 2021
Reported by FDA
February 10, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1

by Taro Pharmaceuticals U.S.A., Inc.

Reason
CGMP deviations.
Recall initiated
January 8, 2021
Reported by FDA
February 10, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall initiated
December 23, 2020
Reported by FDA
February 3, 2021
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30

by Bausch Health Companies, Inc.

Reason
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Recall initiated
January 7, 2021
Reported by FDA
February 3, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

by Bausch Health Companies, Inc.

Reason
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Recall initiated
January 7, 2021
Reported by FDA
February 3, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Incorrect Labeling: Incorrect lot number on secondary packaging
Recall initiated
January 11, 2021
Reported by FDA
February 3, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as Thrifty White Pharmacy Wash-Free Hand Sanitizer. UPC 8 19845 00599 2

by Shane Erickson Inc

Reason
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Recall initiated
December 23, 2020
Reported by FDA
February 3, 2021
Distribution
Nationwide USA and Canada

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Drug Recall Terminated Historical recordClass II

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5

by Shane Erickson Inc

Reason
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Recall initiated
December 23, 2020
Reported by FDA
February 3, 2021
Distribution
Nationwide USA and Canada

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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.