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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

Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-033-16

by Centurion Labs, LLC

Reason: Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Recall initiated: August 22, 2017
Reported by FDA: September 20, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16

by Centurion Labs, LLC

Reason: Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Recall initiated: August 22, 2017
Reported by FDA: September 20, 2017
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

by VistaPharm, Inc.

Reason: Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Recall initiated: August 17, 2017
Reported by FDA: September 20, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16

by Medline Industries Inc

Reason: Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
Recall initiated: August 3, 2017
Reported by FDA: September 20, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8

by Zydus Pharmaceuticals USA Inc

Reason: Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Recall initiated: August 18, 2017
Reported by FDA: September 20, 2017
Distribution: Nationwide within United States

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Drug Recall Terminated Historical recordClass II

Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00316 1.

by Mid Valley Pharmaceutical

Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated: August 30, 2017
Reported by FDA: September 20, 2017
Distribution: TX

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Drug Recall Terminated Historical recordClass II

Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.

by Mid Valley Pharmaceutical

Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated: August 30, 2017
Reported by FDA: September 20, 2017
Distribution: TX

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Drug Recall Terminated Historical recordClass III

AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10

by Ascend Laboratories LLC

Reason: PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Recall initiated: May 5, 2017
Reported by FDA: September 20, 2017
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

by ImprimisRx CA, Inc., dba ImprimisRx

Reason: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Recall initiated: June 23, 2017
Reported by FDA: September 13, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

by ImprimisRx CA, Inc., dba ImprimisRx

Reason: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Recall initiated: June 23, 2017
Reported by FDA: September 13, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

by ImprimisRx CA, Inc., dba ImprimisRx

Reason: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Recall initiated: June 23, 2017
Reported by FDA: September 13, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA

by ImprimisRx CA, Inc., dba ImprimisRx

Reason: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Recall initiated: June 23, 2017
Reported by FDA: September 13, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09

by Degasa Sa De Cv

Reason: Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Recall initiated: August 4, 2017
Reported by FDA: September 13, 2017
Distribution: CA, IL.

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Drug Recall Terminated Historical recordClass III

Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10

by Mckesson Packaging Services

Reason: Failed moisture limits: Out of specification for moisture content.
Recall initiated: August 28, 2017
Reported by FDA: September 13, 2017
Distribution: PA, OH, IL, CO, LA

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Drug Recall Terminated Historical recordClass III

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations
Recall initiated: May 2, 2017
Reported by FDA: September 13, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01

by Tris Pharma Inc.

Reason: Defective container: Oral solution leaking from container.
Recall initiated: June 15, 2017
Reported by FDA: September 6, 2017
Distribution: U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00.

by Morton Grove Pharmaceuticals, Inc.

Reason: Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Recall initiated: August 10, 2017
Reported by FDA: September 6, 2017
Distribution: Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

by Amphastar Pharmaceuticals, Inc.

Reason: Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Recall initiated: August 15, 2017
Reported by FDA: September 6, 2017
Distribution: Distributed throughout the United States

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Drug Recall Terminated Historical recordClass II

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59

by The Harvard Drug Group

Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recall initiated: August 2, 2017
Reported by FDA: August 30, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47

by The Harvard Drug Group

Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recall initiated: August 2, 2017
Reported by FDA: August 30, 2017
Distribution: Nationwide in the USA

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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.