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

6001–6025 of 17772

SevereFDA (Drugs)·D-1353-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1348-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1393-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1356-2020·2020-07-01
Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA
Time-Cap Labs is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis found NDMA impurity above acceptable levels.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1333-2020·2020-07-01
PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
PD-Rx Pharmaceuticals is recalling 1,969 bottles of Metformin Hydrochloride Extended Release 500 mg because FDA analysis detected NDMA impurity above acceptable levels.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1330-2020·2020-07-01
BIOTA Biosciences Recalls Sterile Curcumin Vials Due to Sterility Concerns
BIOTA Biosciences is recalling Sterile Curcumin 50mg/mL vials due to lack of assurance of sterility and the presence of unapproved ingredients.
Product
Sterile Curcumin 50mg/mL, 10 mL vial
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1334-2020·2020-07-01
Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable levels.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1328-2020·2020-07-01
Biota Biosciences Recalls Sterile Cannabidiol Vials Due to Sterility Concerns
Biota Biosciences is recalling sterile cannabidiol vials because they may not be sterile and were marketed without FDA approval.
Product
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1347-2020·2020-07-01
Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1344-2020·2020-07-01
Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1354-2020·2020-07-01
Amneal Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1327-2020·2020-07-01
BIOTA Biosciences Recalls Sterile Curcumin Vials Due to Sterility Concerns
BIOTA Biosciences is recalling sterile curcumin vials because the product lacks assurance of sterility and contains unapproved ingredients.
Product
Sterile Curcumin, 4mg/mL, 10mL vial
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1332-2020·2020-07-01
Teva Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1350-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1345-2020·2020-07-01
Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable intake levels.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1351-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1331-2020·2020-07-01
Teva Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected the impurity NDMA above acceptable intake levels.
Product
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1343-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling 192 bottles of Metformin Hydrochloride Extended-Release Tablets, 500 mg, due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1329-2020·2020-07-01
BIOTA Biosciences Recalls Sterile Cannabidiol and Curcumin Vials
BIOTA Biosciences is recalling sterile Cannabidiol and Curcumin vials due to lack of sterility assurance and lack of FDA approval.
Product
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1326-2020·2020-07-01
BIOTA Biosciences Recalls Sterile Cannabidiol Vials for Sterility Concerns
BIOTA Biosciences is recalling sterile Cannabidiol (CBD) vials due to lack of assurance of sterility and marketing without an approved NDA/ANDA.
Product
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1352-2020·2020-07-01
Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity
Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1370-2020·2020-07-01
Aurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence
Aurobindo Pharma USA is recalling 1,440 bottles of Clozapine 100mg tablets because a consumer reported finding 50mg tablets in the 100mg bottles.
Product
CLOZAPINE — CLOZAPINE (CLOZAPINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1337-2020·2020-07-01
Soft Whisper Dandruff Shampoo Recalled for Water Quality Deviations
A.P. Deauville, LLC is recalling Soft Whisper Dandruff Shampoo because it was produced with water that failed USP specifications.
Product
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1338-2020·2020-07-01
Crown Laboratories Recalls Subpotent Nystatin Cream Tubes
Crown Laboratories is recalling 62,274 tubes of Nystatin Cream because the product failed potency testing at the 9-month interval.
Product
NYSTATIN CREAM — NYSTATIN CREAM (NYSTATIN CREAM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1341-2020·2020-07-01
Alembic Recalls Aripiprazole Tablets Due to Labeling Error
Alembic Pharmaceuticals is recalling aripiprazole tablets because bottles labeled as 2 mg contained 5 mg tablets. The error affects 19,153 bottles distributed nationwide.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
Distributed nationwide

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6001–6025 of 17772