Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7551–7575 of 18015

ModerateFDA (Drugs)·D-1739-2019·2019-08-21
US Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues
US Pharmaceuticals is recalling Kool Comfort Cooling Pain Relief because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee La
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1733-2019·2019-08-21
US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals Inc. is recalling 305 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests.
Product
MAXIMUM STRENGTH HYDROCORTISONE CREAM — MAXIMUM STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1736-2019·2019-08-21
CVS Health Glycerin Suppositories Recalled for Water Quality Issues
US Pharmaceuticals is recalling CVS Health Glycerin Suppositories because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1737-2019·2019-08-21
US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues
US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel Roll-On because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1731-2019·2019-08-21
US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals is recalling Maximum Strength Hydrocortisone Cream with Aloe due to out-of-specification results in the purified water used during manufacturing.
Product
MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE — MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE (HYDROCORTISONE CREAM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1734-2019·2019-08-21
US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals is recalling 651 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
MAXIMUM STRENGTH HYDROCORTISONE CREAM — MAXIMUM STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1844-2019·2019-08-21
Macleods Pharma Recalls Tamsulosin Hydrochloride Capsules for Dissolution Failures
Macleods Pharma USA Inc is recalling Tamsulosin Hydrochloride Capsules because they failed to meet dissolution specifications.
Product
TAMSULOSIN HYDROCHLORIDE — TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1720-2019·2019-08-21
Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Substance
Lupin Pharmaceuticals is recalling specific bottles of Lisinopril and Hydrochlorothiazide tablets due to the presence of brownish or blackish stains and powder.
Product
LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1725-2019·2019-08-21
US Pharmaceuticals Recalls Intensive Healing Eczema Lotion for Water Quality Issues
US Pharmaceuticals is recalling Intensive Healing Eczema Lotion due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.
Product
INTENSIVE HEALING ECZEMA — INTENSIVE HEALING ECZEMA (HYDROCORTISONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1730-2019·2019-08-21
US Pharmaceuticals Recalls Adult Glycerin Suppositories for Water Quality Issues
US Pharmaceuticals is recalling 880 cases of Adult Glycerin Suppositories because purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1741-2019·2019-08-21
US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues
US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1732-2019·2019-08-21
US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals is recalling specific lots of Maximum Strength Hydrocortisone Cream with Aloe because the purified water used in manufacturing failed quality tests.
Product
MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE — MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE (HYDROCORTISONE CREAM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1727-2019·2019-08-21
US Pharmaceuticals Recalls Children's Glycerin Suppositories for Water Quality Issues
US Pharmaceuticals is recalling 76 cases of Children Glycerin Suppositories due to out-of-specification results in the purified water used during manufacturing.
Product
Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1723-2019·2019-08-21
Alvogen Recalls Macrobid Nitrofurantoin Due to Failed Dissolution Specifications
Alvogen, Inc. is recalling 4,272 bottles of Macrobid (nitrofurantoin monohydrate/macrocrystalline) 100 mg tablets because they failed dissolution specifications.
Product
MACROBID — MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1735-2019·2019-08-21
US Pharmaceuticals Recalls Soothe&Cool Protect Moisture Guard Skin Protectant
US Pharmaceuticals is recalling 830 tubes of Soothe&Cool Protect Moisture Guard Skin Protectant due to out-of-specification results for microbial count or organic carbon in purified water.
Product
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1722-2019·2019-08-21
Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications
Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed to meet dissolution specifications.
Product
NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1743-2019·2019-08-21
Glenmark Recalls Clotrimazole and Betamethasone Cream Due to Temperature Abuse
Glenmark Pharmaceuticals is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream due to complaints of a liquidy texture caused by temperature abuse.
Product
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1643-2019·2019-08-14
RXQ Compounding Recalls Copper Injection Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Copper 0.4MG/ML Injection Solution because the product lacks assurance of sterility.
Product
Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0925-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1634-2019·2019-08-14
RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization
RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.
Product
Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1675-2019·2019-08-14
RXQ Compounding Recalls Magnesium Chloride Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Magnesium Chloride Hexahydrate 20% Injection Solution because the product lacks assurance of sterility.
Product
MAGNESIUM CHLORIDE HEXAHYDRATE (PFV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0951-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1713-2019·2019-08-14
RXQ Compounding Recalls Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Turbo Drops ophthalmic solution because the product may not be sterile.
Product
TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0192-81
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1703-2019·2019-08-14
RXQ Compounding Recalls Phenylephrine and Lidocaine Ophthalmic Solution
RXQ Compounding LLC is recalling ophthalmic solution vials due to a lack of assurance of sterility. The product is distributed nationwide.
Product
RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0918-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1646-2019·2019-08-14
RXQ Compounding Recalls Dextrose 50% Injection Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling Dextrose 50% Injection Solution syringes because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Product
DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1715-2019·2019-08-14
RXQ Compounding Recalls Turbo Drops Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Turbo Drops ophthalmic solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Product
TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0205-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1682-2019·2019-08-14
RXQ Compounding Recalls Midazolam Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Product
MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-86
Category
Drug
Distribution
Distributed nationwide

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