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Browse Drug Recalls

207 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 207 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 207 FDA drug recalls in CT.

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DateProductReasonClassFirm
Oct 9, 2020 DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal T... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Derm... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jun 16, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
Feb 24, 2020 Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... Class III Breckenridge Pharmaceutical, Inc
Jan 24, 2020 Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 5199... CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... Class II Breckenridge Pharmaceutical, Inc
Jan 24, 2020 Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51... CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... Class II Breckenridge Pharmaceutical, Inc
Nov 26, 2019 Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road... Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). Class II SCA Pharmaceuticals, LLC
Sep 3, 2019 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml drop... Lack of Processing Controls: Class II Compounded Solutions in Pharmacy
Sep 3, 2019 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. Lack of Processing Controls: Class II Compounded Solutions in Pharmacy
Sep 3, 2019 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 1... Lack of Processing Controls: Class II Compounded Solutions in Pharmacy
Aug 16, 2019 Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (conce... Lack of Assurance of Sterility. Class II SCA Pharmaceuticals, LLC
Mar 7, 2019 Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stabili... Class III Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 22, 2018 Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: OOS resultsduring routine stability testing Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Sep 4, 2018 Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. R... Cross Contamination With Other Products: Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Jun 14, 2018 Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chlor... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL ba... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharm... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syr... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
May 4, 2018 Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxi... GMP Deviations Class II Milbar Laboratories, Inc.
May 4, 2018 B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatol... Microbial Contamination of Non-sterile Product Class II Milbar Laboratories, Inc.
May 4, 2018 Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatolog... Subpotent Class III Milbar Laboratories, Inc.
May 4, 2018 Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60... GMP Deviations Class II Milbar Laboratories, Inc.
May 4, 2018 MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD ... GMP Deviations Class II Milbar Laboratories, Inc.
May 4, 2018 T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.... Subpotent Class III Milbar Laboratories, Inc.
Feb 22, 2018 labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... Class III SCA Pharmaceuticals, LLC.
Dec 14, 2017 SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... Failed Stability Specifications Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2017 Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue... Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer w... Class II Purdue Pharma, LP
Sep 22, 2017 Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist.... Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incor... Class III Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016 DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane ... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 6, 2016 Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dis... Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 31, 2016 Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons,... Failed Dissolution Specifications Class III Purdue Pharma L.P.
Oct 21, 2015 Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, ... Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was foun... Class III Breckenridge Pharmaceutical, Inc
Sep 16, 2015 UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribu... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.
Sep 16, 2015 UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution... CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class III Praxair Inc.

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.