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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 161–180 of 358 recalls

Class IICompleted

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

September 3, 2021 · DrugView details →

Class IICompleted

Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

September 3, 2021 · Drug

View details →

Class IICompleted

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

September 3, 2021 · DrugView details →

Class IICompleted

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals Inc

Lack of Assurance of Sterility

July 9, 2021 · DrugView details →

Class IICompleted

Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals Inc

Lack of Assurance of Sterility

July 9, 2021 · DrugView details →

Class IICompleted

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

Oxford Pharmaceuticals, LLC

Presence of Foreign Tablets/Capsules

May 5, 2021 · DrugView details →

Class IICompleted

Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden

BASF Corporation

Cross contamination: the excipient was found to be contaminated with theophylline.

November 17, 2020 · DrugView details →

Class IICompleted

SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .

AA PRODUCTS INC

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

September 24, 2020 · DrugView details →

Class IICompleted

HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013

RESOURCE RECOVERY & TRADING LLC

cGMP deviations

July 27, 2020 · DrugView details →

Class IICompleted

Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020

RESOURCE RECOVERY & TRADING LLC

cGMP deviations

July 27, 2020 · DrugView details →

Class IICompleted

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

Apotex Inc.

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

May 27, 2020 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

Class IICompleted

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

October 1, 2019 · DrugView details →

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