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Browse Drug Recalls

201 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 201 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 201 FDA drug recalls.

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DateProductReasonClassFirm
Oct 13, 2017 Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packa... Superpotent drug: out of specification result for potency Class II PharMEDium Services, LLC.
Apr 17, 2017 EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,10... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Apr 17, 2017 EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, table... CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class II Syntho Pharmaceuticals, Inc.
Dec 21, 2016 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... Subpotency: due to a low, out of specification test result for assay during stability testing. Class II Teva Pharmaceuticals USA
Nov 22, 2016 PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. Class III Pfizer Inc.
Oct 18, 2016 HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepare... Subpotent Drug: due to failed potency results of 74% (spec. 80-125%). Class III Town and Country Compounding and Consultation S...
Sep 16, 2016 Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 12, 2016 Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottle... Superpotent Drug and Subpotent Drug; potency failures obtained Class II MOORE'S COMPOUNDING PHARMACY
Jun 7, 2016 Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in... Subpotency: product assayed and found OOS for cyproheptadine Class III Lyne Laboratories, Inc.
Feb 11, 2016 Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, t... Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of m... Class I Pharmakon Pharmaceuticals
Jul 17, 2015 fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volu... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 m... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s... Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in ... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Prese... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volu... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syring... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride,... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volum... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe,... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volu... Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential los... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free... Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in s... Class I Pharmedium Services, LLC
Jul 17, 2015 Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a sy... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Tota... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Pre... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Tot... Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in ... Class II Pharmedium Services, LLC
Jul 17, 2015 HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a s... Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential los... Class II Pharmedium Services, LLC
Jul 17, 2015 neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 m... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride,... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syri... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Pres... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volu... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, P... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.