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

4951–4975 of 5062

ModerateFDA (Drugs)·D-0724-2021·2021-08-25
Combipatch Transdermal System Recalled for Failed Stability Specifications
Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.
Product
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0709-2021·2021-08-18
Injectable drug recalled for non-sterility concerns in Texas and Puerto Rico
Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0712-2021·2021-08-18
Injectable morphine-hydromorphone-bupivacaine mixture recalled for non-sterility
Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.
Product
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0715-2021·2021-08-18
Injectable drug recalled due to non-sterility concern
Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot was distributed in Texas and Puerto Rico.
Product
MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0716-2021·2021-08-18
Injectable Drug Recalled for Non-Sterility Risk
Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0714-2021·2021-08-18
Injectable Drug Sufentanil-Bupivacaine-Baclofen Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Product
SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0711-2021·2021-08-18
Injectable Drug Recall: Non-Sterile Hydromorphone-Bupivacaine-Fentanyl
Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0717-2021·2021-08-18
Hydromorphone HCL-Bupivacaine HCL Injectable Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5M
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0718-2021·2021-08-18
Compounded Progesterone Oil Recalled for Non-Sterility Risk
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
Product
C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0706-2021·2021-08-18
Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Product
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0704-2021·2021-08-18
Injectable Drug Bupivacaine HCL-Baclofen PF Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling a bupivacaine HCL-baclofen PF injectable drug (21 mL syringe, Lot #: 09282020@94) distributed in Texas and Puerto Rico due to non-sterility concerns.
Product
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0705-2021·2021-08-18
Injectable drug recalled for non-sterility in Texas and Puerto Rico
Med Shop Total Care Inc. is recalling a Bupivacaine HCL-Lioresal PF injectable drug due to non-sterility concerns. The recall affects a 41 mL syringe product distributed in Texas and Puerto Rico.
Product
BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0710-2021·2021-08-18
Morphine-Bupivacaine Injectable Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes of multiple strengths due to non-sterility. The affected product was distributed to Texas and Puerto Rico.
Product
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0707-2021·2021-08-18
FDA Recalls Non-Sterile Fentanyl-Bupivacaine-Baclofen Injection
Med Shop Total Care Inc. is voluntarily recalling one lot of fentanyl-bupivacaine-baclofen injectable solution due to non-sterility concerns. The product was distributed in Texas and Puerto Rico.
Product
FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0713-2021·2021-08-18
Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.
Product
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0708-2021·2021-08-18
Injectable Drug Syringes Recalled for Non-Sterility
Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0722-2021·2021-08-18
Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation
Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.
Product
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0721-2021·2021-08-18
Nystatin Oral Suspension Recalled Due to CGMP Violation
PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.
Product
NYSTATIN — NYSTATIN (NYSTATIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0720-2021·2021-08-18
Zyprexa Intramuscular Injection Recalled for Manufacturing Defects
Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.
Product
ZYPREXA — ZYPREXA (OLANZAPINE)
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0723-2021·2021-08-18
Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance
PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.
Product
ETHOSUXIMIDE — ETHOSUXIMIDE (ETHOSUXIMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0703-2021·2021-08-18
Venlafaxine 50 mg Tablets Recalled for Wrong Strength
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.
Product
Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0719-2021·2021-08-18
Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination
Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0702-2021·2021-08-11
Succinylcholine Chloride Syringes Recalled for Lack of Sterility Assurance
BayCare Central Pharmacy is recalling Succinylcholine Chloride 100 mg/5 mL syringes due to lack of sterility assurance. The affected lot was distributed in Florida.
Product
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0749-2021·2021-08-11
Vy&Tea herbal tea recalled for unapproved drug ingredient sibutramine
Qikmoov LLC is recalling Vy&Tea herbal tea because FDA analysis detected sibutramine, an ingredient not approved in an NDA or ANDA application. The product was marketed and distributed nationwide and internationally.
Product
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.co
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0697-2021·2021-08-11
Global Hand Sanitizer Recalled Due to Denaturant Deficiency
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.
Product
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
Category
Drug
Distribution
9 states

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4951–4975 of 5062