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Recalls affecting New York

Data last updated: September 7, 2026 at 12:15 AM UTC

17,235 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 IIILow risk
DrugRecalled June 26, 2025

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

Failed Impurity/Degradation Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0528-2025
Lot/product code:
Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 26, 2025

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

Failed Impurity/Degradation Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0529-2025
Lot/product code:
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 16, 2025

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0517-2025
Lot/product code:
Lot number: 1043, Exp. Date 2/10/2026
Recalling firm:
Qualgen, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 11, 2025

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0509-2025
Lot/product code:
Lot # 12250247B, Exp. 01/31/2027
Recalling firm:
Macleods Pharmaceuticals Ltd
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 29, 2025

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

Presence of a foreign substance: black hair found embedded in tablet.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0470-2025
Lot/product code:
Lot #: MLF2401A, Exp 01/31/2026
Recalling firm:
Macleods Pharmaceuticals Ltd
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 19, 2025

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90

Failed Impurities/Degradation Specifications: not meeting quality requirements (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0462-2025
Lot/product code:
Lot #: 17240195, Exp 01/31/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled March 4, 2025

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Cross Contamination

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0311-2025
Lot/product code:
Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled March 4, 2025

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Cross Contamination

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0312-2025
Lot/product code:
Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled February 24, 2025

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

Weaker than it should be Drug: The stability batch showed a weaker than it should be result, which does not meet the product specifications of 90.0-110.0% of the label claim.

FLNY
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0305-2025
Lot/product code:
Lot 24OCT041, Exp 04/26/2025
Recalling firm:
Imprimis NJOF, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled January 16, 2025

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0208-2025
Lot/product code:
Lot #: 2402101UR, Exp 02/28/2027
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 19, 2024

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0183-2025
Lot/product code:
Lot # AC2556A; Exp. 03/2027
Recalling firm:
West-Ward Columbus Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 18, 2024

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.

Labeling: label mix-up

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0175-2025
Lot/product code:
Lot #: 0160, Exp. Date April 26 2026
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 18, 2024

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

Labeling: label mix-up

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0176-2025
Lot/product code:
Lot #: 0160, Exp. Date April 26 2026
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0196-2025
Lot/product code:
Lot #s: KDT0224001B, Exp 08/31/2026; KDT0224002B, Exp 09/30/2026.
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0199-2025
Lot/product code:
Lot: KDC0224001B Exp 09/30/2026
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0195-2025
Lot/product code:
Lot #s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0194-2025
Lot/product code:
Lot #: KDT0124001, Exp 08/31/2026
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0197-2025
Lot/product code:
Lot: KDC0124001A Exp 09/30/2026.
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0193-2025
Lot/product code:
Lot: KDT0224002A, Exp 09/30/2026
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 12, 2024

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0198-2025
Lot/product code:
Lot: KDC0124002B Exp 09/30/2026
Recalling firm:
Akron Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 22, 2024

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Failed Impurities/Degradation Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0117-2025
Lot/product code:
Lot #: T2300653, Exp 01/31/2025; T2303956, T2303750, Exp 06/30/2025; T2304190, T2304987, Exp 08/31/2025; T2302026, Exp 03/31/2025; T2302526, Exp 05/31/2025.
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 14, 2024

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

Labeling: Not Elsewhere Classified - Wrong NDC number

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0102-2025
Lot/product code:
Lot#: M408002, Exp 05/31/2026
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled October 29, 2024

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Failed Tablet/Capsule Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0047-2025
Lot/product code:
Lot #: C5406201, Exp 03/31/2028
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 30, 2024

Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Defective Container: Firm received complaints of broken tube at the seal.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0002-2025
Lot/product code:
Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 25, 2024

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0033-2025
Lot/product code:
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
Recalling firm:
Denison Pharmaceuticals, LLC
View official FDA record (opens in a new tab)