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

7151–7175 of 17974

SevereFDA (Drugs)·D-0147-2020·2019-10-30
Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 1,855 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.
Product
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0148-2020·2019-10-30
Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 1,370 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.
Product
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0150-2020·2019-10-30
Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns
Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0151-2020·2019-10-30
Nephron Recalls del Nido Cardioplegia Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 1,047 bags of del Nido Cardioplegia Solution because the bags may leak, compromising sterility.
Product
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0140-2020·2019-10-23
Macleods Pharma Recalls Pioglitazone Tablets Due to Superpotent Content
Macleods Pharma USA is recalling 31,968 bottles of Pioglitazone Hydrochloride 15 mg tablets because the product is superpotent.
Product
PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0141-2020·2019-10-23
Spectrum Chemical Recalls Fentanyl Citrate Due to Glass Contamination
Spectrum Laboratory Products is recalling Fentanyl Citrate USP active pharmaceutical ingredient due to potential glass contamination. The product was distributed to compounding pharmacies and labs in four states.
Product
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0144-2020·2019-10-23
Atlas Pharmaceuticals Recalls Ascorbic Acid Injection Due to Corn Source Labeling Error
Atlas Pharmaceuticals is recalling Ascorbic Acid Sterile Injection Solution vials labeled as 'Non-Corn Source' but actually derived from corn. The recall affects 1,646 vials distributed to healthcare facilities in Arizona and Colorado.
Product
Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0146-2020·2019-10-23
Ingenus Recalls Leucovorin Calcium Injection Due to Crystallization
Ingenus Pharmaceuticals is recalling Leucovorin Calcium Injection vials due to the presence of particulate matter identified as API crystallization.
Product
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0145-2020·2019-10-23
Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration
Jubilant Cadista Pharmaceuticals is recalling specific lots of Pantoprazole Sodium Delayed Release Tablets due to dark brown discoloration on tablet edges.
Product
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0143-2020·2019-10-23
Aurobindo Recalls Amphetamine Mixed Salts Tablets for Out-of-Specification Weight
Aurobindo Pharma USA Inc. is recalling 11,129 bottles of 20mg Amphetamine Mixed Salts tablets because they failed weight and thickness specifications.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0142-2020·2019-10-23
KVK-Tech Recalls Methylphenidate Hydrochloride Oral Solution Due to Foreign Particles
KVK-Tech is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution because of the presence of fiber particles.
Product
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0126-2020·2019-10-16
Major Infants' Gas Relief Drops Recalled for Microbial Contamination
GCP Laboratories is recalling Major Infants' Gas Relief Drops due to microbial contamination of the non-sterile product.
Product
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0133-2020·2019-10-16
DrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Product
DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0128-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection
Sandoz is recalling 13,130 bottles of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0127-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity
Sandoz is recalling specific lots of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0130-2020·2019-10-16
Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure
Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0129-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection
Sandoz is recalling Ranitidine Hydrochloride Capsules 300mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0135-2020·2019-10-16
Epic Pharma Recalls Estradiol Tablets Due to Foreign Tablet Presence
Epic Pharma is recalling Estradiol 0.5 mg tablets because 1 mg tablets were found in the bottles. Patients should stop using the product and contact their healthcare provider.
Product
ESTRADIOL — ESTRADIOL (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0136-2020·2019-10-16
Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns
Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.
Product
LMD IN DEXTROSE — LMD IN DEXTROSE (DEXTRAN 40)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0132-2020·2019-10-16
DrKids Children's Natural Cough Syrup Recalled for Potential B. cepacia Contamination
Unipharma, LLC is recalling DrKids Children's Natural Cough Syrup due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Product
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0139-2020·2019-10-16
Mylan Recalls Rifampin Injection Vials Due to Impurity Concerns
Mylan Laboratories is recalling 19,165 vials of Rifampin for Injection due to elevated unknown impurities that may reduce product effectiveness.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0137-2020·2019-10-16
Guerbet Recalls Optiray Syringes Due to RFID Formatting Error
Guerbet LLC is recalling 3,860 Optiray syringes because an RFID formatting error causes the injector to read the product as expired, preventing injection.
Product
OPTIRAY — OPTIRAY (IOVERSOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0134-2020·2019-10-16
Amneal Recalls Benazepril HCl Tablets Due to Foreign Tablet Presence
Amneal Pharmaceuticals is recalling Benazepril HCl 40 mg tablets because a Promethazine HCl tablet was found in the bottle.
Product
BENAZEPRIL HYDROCHLORIDE — BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0131-2020·2019-10-16
Teva Recalls Matzim LA Tablets Due to GMP Deviation
Teva Pharmaceuticals USA is recalling 5,849 bottles of Matzim LA (Diltiazem Hydrochloride) 240 mg tablets because the lot was not intended for commercial distribution.
Product
MATZIM LA — MATZIM LA (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-0138-2020·2019-10-16
Guerbet Recalls Sodium Chloride Syringes Due to RFID Formatting Error
Guerbet LLC is recalling 3,140 prefilled sodium chloride syringes because an RFID formatting error prevents the Optivantage injector from administering the product.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide

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7151–7175 of 17974