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Recalls affecting Kentucky

Data last updated: September 8, 2026 at 1:13 PM UTC

16,694 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
NewestOldest
High riskLow riskAll
Wording
Class IIModerate risk
DrugRecalled October 1, 2019

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

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0175-2020
Lot/product code:
Batch Numbers: All lots within expiry.
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 1, 2019

Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0168-2020
Lot/product code:
Batch Numbers: All lots within expiry.
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 4, 2019

Nana's Been a Nut Bread NET WT. 11oz/311.74g cloth bag CONTAINS WHEAT AND SOY. MADE ON EQUIPMENT THAT MAKES PRODUCTS CONTAINING WHEAT, EGGS, MILK, SOY AND TREE NUTS. GULLAH BOURMET Inc. CHARLESTON, SC 29407 UPC 6 50305 01045 9

The product ingredient statement does not list walnuts in the product.

ALFLGAINKYLAMDMNMSNCNYOHPASCTNVA
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-0036-2020
Lot/product code:
Item #: 1045. Expiration date 01/30/2020
Recalling firm:
Gullah Gourmet, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0538-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0536-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0537-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0534-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0543-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0542-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0540-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0539-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0544-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0541-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0535-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0545-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0527-2020
Lot/product code:
RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0528-2020
Lot/product code:
RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0530-2020
Lot/product code:
RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0526-2020
Lot/product code:
Lot # NBSB19001DA3; Exp FEB 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0529-2020
Lot/product code:
UI1519001-A UI1519002-A UI1519003-A UI1519004-A
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0612-2020
Lot/product code:
AR171764A 11/2019 AR171875A 11/2019 AR171876A 11/2019 AR171981A 11/2019 AR180020C 1/2020 AR180206A 1/2020 AR180207A 1/2020 AR180208A 1/2020 AR180438A 2/2020 AR180439A 2/2020 AR180481A 3/2020 AR180482A 3/2020 AR180483A 3/2020 AR181690A 10/2020 AR181691A 10/2020 AR181806A 11/2020 AR190058A 12/2020 AR190059A 12/2020 AR190183A 1/2021 AR190184A 1/2021 AR171984A 12/2019 AR180020B 1/2020 AR180675A 4/2020 AR180868B 5/2020 AR181807A 11/2020 AR190366B 2/2021 AR171986A 12/2019 AR171987A 12/2019 AR180255A 1/2020 AR180441A 2/2020 AR180442A 2/2020 AR180559A 3/2020 AR180560A 3/2020 AR180594A 3/2020 AR180595A 3/2020 AR180829A 4/2020 AR180831A 5/2020 AR180832A 5/2020 AR180868A 5/2020 AR181807C 11/2020 AR190085A 12/2020 AR190086A 12/2020 AR190087A 12/2020 AR190124A 1/2021 AR190542B 3/2021 AR190609A 3/2021 AR190610A 3/2021 AR171875B 11/2019 AR180483B 3/2020 AR181807B 11/2020 AR190008B 12/2020 AR171763A 11/2019 AR171764B 11/2019 AR171874A 11/2019 AR171875C 11/2019 AR171877B 11/2019 AR171878B 11/2019 AR171982A 11/2019 AR171983A 12/2019 AR171985A 12/2019 AR180016A 12/2019 AR180017A 12/2019 AR180018A 12/2019 AR180019A 12/2019 AR180020A 1/2020 AR180208B 1/2020 AR180256A 1/2020 AR180291A 1/2020 AR180292A 1/2020 AR180293A 1/2020 AR180294A 2/2020 AR180295A 2/2020 AR180364A 2/2020 AR180365A 2/2020 AR180366A 2/2020 AR180367A 2/2020 AR180368A 2/2020 AR180440B 2/2020 AR180484A 3/2020 AR180485A 3/2020 AR180556A 3/2020 AR180557A 3/2020 AR180558A 3/2020 AR180596A 3/2020 AR180597A 3/2020 AR180598A 3/2020 AR180599A 3/2020 AR180675B 4/2020 AR180676A 4/2020 AR180677A 4/2020 AR180678A 4/2020 AR180679A 4/2020 AR180801A 4/2020 AR180802A 4/2020 AR180803A 4/2020 AR180869A 5/2020 AR180870A 5/2020 AR180871A 5/2020 AR180872A 5/2020 AR180994A 5/2020 AR180995A 5/2020 AR180996A 5/2020 AR180997A 6/2020 AR180998A 6/2020 AR181158A 7/2020 AR181159A 7/2020 AR181160A 7/2020 AR181161A 7/2020 AR181692A 10/2020 AR181693A 10/2020 AR181694A 10/2020 AR181709A 10/2020 AR181710A 11/2020 AR181711A 11/2020 AR181808A 11/2020 AR181809A 11/2020 AR190004A 12/2020 AR190005A 12/2020 AR190006A 12/2020 AR190007A 12/2020 AR190008A 12/2020 AR190088A 12/2020 AR190089A 12/2020 AR190090A 12/2020 AR190121A 12/2020 AR190122A 12/2020 AR190123A 12/2020 AR190125B 1/2021 AR190181A 1/2021 AR190182A 1/2021 AR190364A 2/2021 AR190365A 2/2021 AR190366A 2/2021 AR190509A 3/2021 AR190510A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0615-2020
Lot/product code:
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0614-2020
Lot/product code:
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0613-2020
Lot/product code:
AR172033B 11/2019 AR180024A 12/2019 AR180025A 12/2019 AR180118A 12/2019 AR180119A 12/2019 AR180519A 3/2020 AR180615A 3/2020 AR181795A 11/2020 AR181921B 12/2020 AR190705A 4/2021 AR172029A 11/2019 AR172030A 11/2019 AR180021A 12/2019 AR180022A 12/2019 AR180023A 12/2019 AR180123A 12/2019 AR180144A 1/2020 AR180145A 1/2020 AR180146A 1/2020 AR180147A 1/2020 AR180402A 2/2020 AR180465A 2/2020 AR180466A 2/2020 AR180467A 2/2020 AR180468A 2/2020 AR180613A 3/2020 AR181156A 7/2020 AR181157A 7/2020 AR190418B 2/2021 AR171800A 11/2019 AR171801A 11/2019 AR171802A 11/2019 AR171803A 11/2019 AR171804A 11/2019 AR171931A 11/2019 AR171932A 11/2019 AR171933A 11/2019 AR171934A 11/2019 AR171935A 11/2019 AR171936A 11/2019 AR171937A 11/2019 AR172026A 11/2019 AR172027A 11/2019 AR172028A 11/2019 AR172031A 11/2019 AR172032A 11/2019 AR172033A 11/2019 AR172034A 11/2019 AR172035A 11/2019 AR180030A 12/2019 AR180031A 12/2019 AR180032A 12/2019 AR180033A 12/2019 AR180034A 12/2019 AR180113A 12/2019 AR180114A 12/2019 AR180115A 12/2019 AR180117A 12/2019 AR180120A 12/2019 AR180121A 12/2019 AR180122A 12/2019 AR180148A 1/2020 AR180198A 1/2020 AR180199A 1/2020 AR180200A 1/2020 AR180201A 1/2020 AR180202A 1/2020 AR180257A 1/2020 AR180258A 1/2020 AR180335A 2/2020 AR180336A 2/2020 AR180337A 2/2020 AR180338A 2/2020 AR180339A 2/2020 AR180374A 2/2020 AR180375A 2/2020 AR180376B 2/2020 AR180403A 2/2020 AR180404A 2/2020 AR180405A 2/2020 AR180406A 2/2020 AR180424A 2/2020 AR180486A 3/2020 AR180487A 3/2020 AR180488A 3/2020 AR180515A 3/2020 AR180516A 3/2020 AR180517A 3/2020 AR180518A 3/2020 AR180638A 3/2020 AR180640A 4/2020 AR180641A 4/2020 AR181920A 12/2020 AR181921A 12/2020 AR190414B 2/2021 AR190415A 2/2021 AR190416A 2/2021 AR190417A 2/2021 AR190418A 2/2021 AR190543A 3/2021 AR190544A 3/2021 AR190545A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0616-2020
Lot/product code:
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)