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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 Terminated Historical recordClass II

fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64

by SCA Pharmaceuticals, LLC

Reason: Lack Of Assurance Of Sterility.
Recall initiated: October 19, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40

by SCA Pharmaceuticals, LLC

Reason: Lack Of Assurance Of Sterility.
Recall initiated: October 19, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22

by SCA Pharmaceuticals, LLC

Reason: Lack Of Assurance Of Sterility.
Recall initiated: October 19, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17

by SCA Pharmaceuticals, LLC

Reason: Lack Of Assurance Of Sterility.
Recall initiated: October 19, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29

by SCA Pharmaceuticals, LLC

Reason: Lack Of Assurance Of Sterility.
Recall initiated: October 19, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014

by Kiriko, LLC.

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Recall initiated: October 6, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.

by Precision Dose Inc.

Reason: Subpotent Drug: low out of specification results.
Recall initiated: September 25, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

by Sanofi-Aventis U.S. LLC

Reason: Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Recall initiated: October 13, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.

by AVKARE Inc.

Reason: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Recall initiated: October 6, 2017
Reported by FDA: November 8, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC # 0363001726, UPC # 049022889125

by Vi-Jon, Inc.

Reason: Failed Stability Specifications
Recall initiated: September 13, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.

by Aidarex Pharmaceuticals LLC

Reason: Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Recall initiated: September 5, 2017
Reported by FDA: November 1, 2017
Distribution: Product was distributed in Florida

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Drug Recall Terminated Historical recordClass III

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

by Teva Pharmaceuticals USA

Reason: Failed Dissolution Specifications: Low out of specification results for dissolution.
Recall initiated: October 17, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;

by Wockhardt Usa Inc.

Reason: Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Recall initiated: August 22, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-03

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-02

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-01

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-05.

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-04

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06

by PharMEDium Services, LLC

Reason: Subpotent Drug
Recall initiated: September 1, 2017
Reported by FDA: November 1, 2017
Distribution: Nationwide.

View recall →

Data last updated: September 24, 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.