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Recalls affecting South Dakota

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

16,341 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 July 3, 2020

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India

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

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-1386-2020
Lot/product code:
a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
Recalling firm:
Granules Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0078-2021
Lot/product code:
all lots
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0080-2021
Lot/product code:
1931102AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0081-2021
Lot/product code:
1931101AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0079-2021
Lot/product code:
1931104AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

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-0082-2021
Lot/product code:
Lots ending in 1001,1002, 1003, 1004, 1005.
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 10, 2020

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

Failed Stability Specifications: not meeting quality requirements result for enzyme activity levels noted during routine stability testing.

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-1507-2020
Lot/product code:
Lot #: A9306, Exp 2/28/2022
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427.

Weaker than it should be Drug; Killz GERMz was recalled due to weaker than it should be results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

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-0041-2021
Lot/product code:
Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with weaker than it should be ethanol levels.

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-0038-2021
Lot/product code:
Lot #: 37009, Exp. 02/10/2021
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with weaker than it should be ethanol levels.

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-0039-2021
Lot/product code:
Lot #: 37009, Exp. 02/10/2021
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with weaker than it should be ethanol levels.

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-0037-2021
Lot/product code:
Lot #: 072120, Exp. 01/21/2022
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.

Weaker than it should be Drug; Killz GERMz was recalled due to weaker than it should be results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

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-0040-2021
Lot/product code:
Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 8, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

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-0057-2021
Lot/product code:
a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
Recalling firm:
Denton Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 8, 2020

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

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-0056-2021
Lot/product code:
N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
Recalling firm:
Denton Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower Butter. SKU: TB-BASTSB-5 and TB-BASTSB-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015089.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

ALARAZCACOCTDEFLGAIAIDILINKSKYLAMAMDMEMIMNMOMSNCNHNJNVNYOHORPASCSDTNTXUTVAVIWAWI
▸Full report

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

Recall #:
F-0068-2021
Lot/product code:
BB 13 APR 2021 20104 BB 08 MAY 2021 20129 BB 20 MAY 2021 20141 BB 21 MAY 2021 20142 BB 08 JUN 2021 20160 BB 09 JUN 2021 20161 BB 15 JUN 2021 20167
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015072.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

ALARAZCACOCTDEFLGAIAIDILINKSKYLAMAMDMEMIMNMOMSNCNHNJNVNYOHORPASCSDTNTXUTVAVIWAWI
▸Full report

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

Recall #:
F-0067-2021
Lot/product code:
BB 07 APR 2021 20098 BB 08 APR 2021 20099 BB 09 APR 2021 20100 BB 18 MAY 2021 20139 BB 19 MAY 2021 20140 BB 16 JUN 2021 20168 BB 28 AUG 2021 20241
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Raspberry. SKU: KB-BLRB-5. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.99 oz(28g) and packed in 5 pack box (Net Wt. 4.95 OZ (140g). UPC code: 819573014389.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

ALARAZCACOCTDEFLGAIAIDILINKSKYLAMAMDMEMIMNMOMSNCNHNJNVNYOHORPASCSDTNTXUTVAVIWAWI
▸Full report

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

Recall #:
F-0069-2021
Lot/product code:
BB 14 APR 2021 20105 BB 05 MAY 2021 20126 BB 11 MAY 2021 20132 BB 01 JUN 2021 20153 BB 08 JUL 2021 20190 BB 13 JUL 2021 20195 BB 04 AUG 2021 20217
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-0068-2021
Lot/product code:
MET100201, MET100401 EXP 05/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-0067-2021
Lot/product code:
MET200101, MET200301 EXP 05/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2020

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

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

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-0149-2021
Lot/product code:
Batch # 18472036, 18472041.
Recalling firm:
BASF Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled November 17, 2020

PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY and IMMUNE HEALTH Dietary Supplement 30 Servings (45g) Supplement Facts***Hordenine HCL*** Manufactured by: Fusion Health Vitality, LLC 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004 888.964.5327 UPC 7 28028 21054 5

The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements

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 #:
F-0180-2021
Lot/product code:
Lot # s: 200313, 200321, 200326, 200402, 200406, 200410, 200414, 200416, 200424, 200501, 200525, 200527, 200604 & 200610.
Recalling firm:
Fusion Health and Vitality LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 28, 2020

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

CGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

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-0222-2021
Lot/product code:
ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
Recalling firm:
Sunstar Americas, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 4, 2021

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-0227-2021
Lot/product code:
MET200501 07/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 25, 2021

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

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-0249-2021
Lot/product code:
Lot MET200601, 07/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 27, 2021

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

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-0304-2021
Lot/product code:
Lot #: 148992, Exp 5/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)