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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

Sildenafil 200 mg Troche (Clinic)

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

Progesterone E4M SR 100 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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Drug Recall Terminated Historical recordClass II

Progesterone 50 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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Drug Recall Terminated Historical recordClass II

Progesterone 200 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

Naltrexone 4.5 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

Magic Bullet Supplement

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

Liothyronine (T3) 92.5 MCG

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

Liothyronine (T3) 80 mcg SR cap

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

Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars

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

Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars

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

Finasteride/Biotin 1 mg/50 mcg

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

DHEA/Pregnenol One 10.25 MG Cap

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 III

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

by Hikma Pharmaceuticals USA Inc.

Reason: Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Recall initiated: January 14, 2020
Reported by FDA: January 29, 2020
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302

by Tuscano and Delucia Group (DBA Entropic Labs)

Reason: Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Recall initiated: August 24, 2019
Reported by FDA: January 29, 2020
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

by Advanced Accelerator Applications USA, Inc.

Reason: Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Recall initiated: January 10, 2020
Reported by FDA: January 29, 2020
Distribution: Nationwide in the US and Canada

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Drug Recall Terminated Historical recordClass II

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

by RemedyRePack Inc.

Reason: CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Recall initiated: December 11, 2019
Reported by FDA: January 29, 2020
Distribution: Product was distributed to two facilities in CA and NY.

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Drug Recall Terminated Historical recordClass II

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)

by Preferred Pharmaceuticals, Inc

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: January 7, 2020
Reported by FDA: January 29, 2020
Distribution: Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC

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Drug Recall Terminated Historical recordClass II

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)

by Preferred Pharmaceuticals, Inc

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: January 7, 2020
Reported by FDA: January 29, 2020
Distribution: Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC

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Drug Recall Terminated Historical recordClass II

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

by Denton Pharma, Inc.

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: December 20, 2019
Reported by FDA: January 29, 2020
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.

by Denton Pharma, Inc.

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: December 20, 2019
Reported by FDA: January 29, 2020
Distribution: Nationwide

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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.