Drug Recalls — FDA Recall Database

10,690drug recall records

953FDA Class I records

8firms with 5+ records

Aidapak Services, LLC537 records

Database records

Records — page 258

10,690 detailed records are currently available in this category.

DrugOct 19, 2016

Pharmedium Services lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL recall — FDA D-0064-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Leiter's Compounding Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for recall — FDA D-0014-2017

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative recall — FDA D-0093-2017

Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.

Class IFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total recall — FDA D-0034-2017

Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a recall — FDA D-0046-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total recall — FDA D-0071-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose recall — FDA D-0097-2017

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…

Class IIFDA: TerminatedHospira Inc., A Pfizer Company

DrugOct 19, 2016

Pharmedium Services HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium recall — FDA D-0050-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL recall — FDA D-0054-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a recall — FDA D-0045-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Bee Xtreme Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles recall — FDA D-0021-2017

Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein

Class IFDA: TerminatedBee Xtreme

DrugOct 19, 2016

Leiter's Compounding Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) recall — FDA D-0015-2017

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Pharmedium Services PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium recall — FDA D-0085-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 recall — FDA D-0055-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Bee Xtreme La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles recall — FDA D-0019-2017

Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein

Class IFDA: TerminatedBee Xtreme

DrugOct 19, 2016

Pharmedium Services atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total recall — FDA D-0025-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride recall — FDA D-0078-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume recall — FDA D-0070-2017

Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative recall — FDA D-0031-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium recall — FDA D-0040-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total recall — FDA D-0037-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 12, 2016

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count recall — FDA D-0007-2017

Failed Dissolution Specifications

Class IIIFDA: TerminatedSun Pharmaceutical Industries, Inc.

DrugOct 5, 2016

Mckesson Packaging Services Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister recall — FDA D-1527-2016

Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

Class IIIFDA: TerminatedMckesson Packaging Services

DrugOct 5, 2016

Pharmatech Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by recall — FDA D-1524-2016

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Class IIFDA: TerminatedPharmatech LLC

How to use this drug recall index

A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.

Drug Recalls in the United States

Records — page 258

How to use this drug recall index

What the database can and cannot tell you