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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

methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).

by Teva Pharmaceuticals USA

Reason: CGMP Deviations
Recall initiated: July 29, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

by Bee Xtreme

Reason: Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Recall initiated: December 23, 2015
Reported by FDA: October 19, 2016
Distribution: Unknown

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Drug Recall Terminated Historical recordClass II

TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.

by Allergan Sales, LLC

Reason: Failed Content Uniformity Specifications
Recall initiated: June 30, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.

by Allergan Sales, LLC

Reason: Failed Content Uniformity Specifications
Recall initiated: June 30, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: August 29, 2016
Reported by FDA: October 19, 2016
Distribution: nationwide

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Drug Recall Terminated Historical recordClass II

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.

by Hospira Inc., A Pfizer Company

Reason: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Recall initiated: September 16, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.

by Hospira Inc., A Pfizer Company

Reason: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Recall initiated: September 16, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Recall initiated: September 13, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass I

5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

by B. Braun Medical Inc

Reason: Non-Sterility: fungal contamination due to leaking containers.
Recall initiated: March 25, 2016
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass I

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

by PharMEDium Services, LLC

Reason: Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.

by PharMEDium Services, LLC

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated: July 17, 2015
Reported by FDA: October 19, 2016
Distribution: Nationwide

View recall →

Data last updated: September 25, 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.