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 17762

ModerateFDA (Drugs)·D-0880-2021·2021-10-06
Z-107 Formula Soft Tissue Healing Recalled for Out-of-Specification Test Results
Washington Homeopathic Products, Inc. is recalling Z-107 Formula Soft Tissue Healing due to out-of-specification test results from identification testing. The product was distributed nationwide.
Product
Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum M
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0853-2021·2021-10-06
CVS Health Daytime Cold & Flu Relief Drug Recalled for Subpotency
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials are being recalled because the product is subpotent—containing less active ingredient than intended. The recall affects specific lot numbers distributed across 14 U.S. states.
Product
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
Category
Drug
Distribution
14 states
SevereFDA (Drugs)·D-0827-2021·2021-09-29
Arformoterol Tartrate Inhalation Solution Recall Due to Sterility Assurance
Glenmark Pharmaceuticals is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL nationwide because the manufacturer lacks assurance of sterility for affected lots.
Product
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65;
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0820-2021·2021-09-29
Fulvestrant Injection Recall: Lack of Sterility Assurance
Glenmark Pharmaceuticals is recalling Fulvestrant Injection 250 mg/5 mL due to lack of assurance of sterility. The affected product was distributed nationwide in 28,658 cartons across multiple lots.
Product
FULVESTRANT — FULVESTRANT (FULVESTRANT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0819-2021·2021-09-29
X Rated Honey For Men Recalled for Undisclosed Tadalafil
Phe Inc is recalling X Rated Honey For Men packets nationwide because the product contains Tadalafil and was marketed without FDA approval. Consumers should stop use immediately.
Product
X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0830-2021·2021-09-29
Avicel RC-591 NF Bulk Powder Recalled for Microbial Contamination
DuPont Nutrition USA is recalling Avicel RC-591 NF bulk powder (lot #2173766940) due to out-of-specification microbial contamination. The product was distributed as a component in finished drug formulations nationwide.
Product
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0812-2021·2021-09-29
Metoprolol Tartrate Tablets Recalled for Metal Wire Contamination
Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate 100 mg tablets due to the presence of metal wire found in at least one tablet. The FDA classified this as a Class II recall affecting 2,820 bottles distributed nationwide.
Product
METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0815-2021·2021-09-29
Promethazine With Codeine Oral Solution Recall Due to Microbial Contamination
Morton Grove Pharmaceuticals is recalling Promethazine With Codeine Oral Solution (Lot #UV1198) nationwide due to potential microbial contamination in liquid sugar batches used during manufacturing.
Product
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC:
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0807-2021·2021-09-29
Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications
The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.
Product
CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0816-2021·2021-09-29
Valproic Acid Oral Solution recalled for microbial contamination
Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.
Product
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0818-2021·2021-09-29
Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues
Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.
Product
HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0809-2021·2021-09-29
Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity
Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.
Product
CHANTIX — CHANTIX (VARENICLINE TARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0810-2021·2021-09-29
Chantix Varenicline Tablets Recalled for N-Nitroso Impurity
Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.
Product
CHANTIX — CHANTIX (VARENICLINE TARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0824-2021·2021-09-29
Chlorzoxazone 750 mg Tablets Recalled Due to CGMP Deviations
Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.
Product
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0808-2021·2021-09-29
Chantix Varenicline Tablets Recalled for Nitroso Impurity
Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.
Product
Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0825-2021·2021-09-29
Zonisamide Capsules Recalled for Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.
Product
ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0811-2021·2021-09-29
Chantix (Varenicline) Tablets Recalled for Impurity Above FDA Limits
Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.
Product
Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0806-2021·2021-09-29
Entacapone Tablets Recalled for Failed Dissolution Specifications
The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.
Product
ENTACAPONE — ENTACAPONE (ENTACAPONE)
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0813-2021·2021-09-29
Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications
American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.
Product
SIROLIMUS — SIROLIMUS (SIROLIMUS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0822-2021·2021-09-29
Glenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.
Product
NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0828-2021·2021-09-29
Betadine Povidone-Iodine Solution Swabstick recalled for subpotent drug
Avrio Health L.P. is recalling Betadine Solution Swabstick in single and three-count packages nationwide because the product is subpotent—meaning it contains less active ingredient than specified. Consumers should stop using affected lots and consult their healthcare provider if needed.
Product
BETADINE — BETADINE (POVIDONE-IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0826-2021·2021-09-29
Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.
Product
ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0829-2021·2021-09-29
Zonisamide 100 mg Capsules Recalled Due to Quality Control Gaps
Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.
Product
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0823-2021·2021-09-29
Drug Recall: Chlorzoxazone Tablets Due to Manufacturing Deviations
Glenmark Pharmaceuticals is recalling 1,800 bottles of Chlorzoxazone Tablets USP 375 mg nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on August 27, 2021.
Product
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0814-2021·2021-09-29
Promethazine Syrup Plain Recall Due to Microbial Contamination
Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.
Product
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
Category
Drug
Distribution
Distributed nationwide

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4951–4975 of 17762