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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 I

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Recall initiated: December 20, 2019
Reported by FDA: February 19, 2020
Distribution: Nationwide in the U.S. and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09

by Macleods Pharma Usa Inc

Reason: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Recall initiated: January 24, 2020
Reported by FDA: February 12, 2020
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.

by Graviti Pharmaceuticals Private Limited

Reason: Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Recall initiated: January 28, 2020
Reported by FDA: February 12, 2020
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01

by Teva Pharmaceuticals USA

Reason: GMP Deviations: Product bottle may be absent of desiccant.
Recall initiated: January 27, 2020
Reported by FDA: February 12, 2020
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01

by Teva Pharmaceuticals USA

Reason: GMP Deviations: Product bottle may be absent of desiccant.
Recall initiated: January 27, 2020
Reported by FDA: February 12, 2020
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01

by UNICHEM PHARMACEUTICALS USA INC

Reason: Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Recall initiated: January 29, 2020
Reported by FDA: February 12, 2020
Distribution: Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.

by Ascend Laboratories LLC

Reason: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Recall initiated: January 24, 2020
Reported by FDA: February 12, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass III

Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.

by Ascend Laboratories LLC

Reason: Failed Dissolution Specifications: low out of specification results for dissolution testing.
Recall initiated: January 22, 2020
Reported by FDA: February 12, 2020
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Recall initiated: January 10, 2020
Reported by FDA: February 12, 2020
Distribution: AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN

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Drug Recall Terminated Historical recordClass II

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

by Spectrum Laboratory Products

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: January 14, 2020
Reported by FDA: February 12, 2020
Distribution: The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.

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Drug Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

by Pharmaceutical Associates Inc

Reason: Subpotent: Out of specification for assay at the 12-month time point.
Recall initiated: January 14, 2020
Reported by FDA: February 5, 2020
Distribution: Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10

by Macleods Pharma Usa Inc

Reason: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Recall initiated: January 20, 2020
Reported by FDA: February 5, 2020
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11

by Shandex Personal Care Manufacturing Inc.

Reason: Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
Recall initiated: January 16, 2020
Reported by FDA: February 5, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704

by McGuff Compounding Pharmacy Services, Inc.

Reason: Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Recall initiated: February 14, 2019
Reported by FDA: February 5, 2020
Distribution: Prescriptions filled for patients in the following states: AK, AZ, CA, CO, DC, FL, IN, MA, MT, NC, NJ, NY, OR, SC, TX, UT, VA, WA, and WI.

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Drug Recall Terminated Historical recordClass II

Testosterone Topical Cream 4%

by MPRX, Inc. dba Medical Park Pharmacy

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Recall initiated: December 18, 2019
Reported by FDA: February 5, 2020
Distribution: TX

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Drug Recall Terminated Historical recordClass II

Tadalafil 6 mg Capsule

by MPRX, Inc. dba Medical Park Pharmacy

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Recall initiated: December 18, 2019
Reported by FDA: February 5, 2020
Distribution: TX

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Drug Recall Terminated Historical recordClass II

Tadalafil 20 mg Troche

by MPRX, Inc. dba Medical Park Pharmacy

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Recall initiated: December 18, 2019
Reported by FDA: February 5, 2020
Distribution: TX

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Drug Recall Terminated Historical recordClass II

T3/T4 SR 9 mcg/38 mcg capsule

by MPRX, Inc. dba Medical Park Pharmacy

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Recall initiated: December 18, 2019
Reported by FDA: February 5, 2020
Distribution: TX

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Drug Recall Terminated Historical recordClass II

Squaric Acid 0.1% Topical Solution (Clinic) 30 mL

by MPRX, Inc. dba Medical Park Pharmacy

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Recall initiated: December 18, 2019
Reported by FDA: February 5, 2020
Distribution: TX

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Drug Recall Terminated Historical recordClass II

Sildenafil 80 mg capsules

by MPRX, Inc. dba Medical Park Pharmacy

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Recall initiated: December 18, 2019
Reported by FDA: February 5, 2020
Distribution: TX

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Data last updated: September 17, 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.