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

4351–4375 of 17964

ModerateFDA (Drugs)·D-0716-2022·2022-02-23
Erythromycin Topical Gel Recalled for Failed Impurity Specifications
Teligent Pharma is recalling one lot of Erythromycin Topical Gel USP 2% because the product failed to meet specifications for unknown maximum related compounds.
Product
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0556-2022·2022-02-16
Polymyxin B for Injection Recalled Due to Particulate Matter Contamination
AuroMedics Pharma LLC is recalling Polymyxin B for Injection USP (Lot CPB200013) nationwide due to the presence of particulate matter, including hair, found in vials.
Product
POLYMYXIN B — POLYMYXIN B (POLYMYXIN B)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0557-2022·2022-02-16
MegMan Performance Booster capsules recalled for undeclared tadalafil
Junp Hydration LLC is recalling MegMan Performance Booster 800 mg capsules because the product contains undeclared tadalafil, an active pharmaceutical ingredient not listed on the label, making it an unapproved drug.
Product
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0561-2022·2022-02-16
HARD DAWN Rise and Shine Capsules Recalled for Undisclosed Tadalafil
HARD DAWN Rise and Shine capsules (500 mg) are being recalled because they contain tadalafil, an FDA-approved drug, without proper approval or labeling. The product was sold nationwide via Amazon.
Product
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0531-2022·2022-02-16
Acetaminophen 325 mg bulk tablets recalled for manufacturing deviations
ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.
Product
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0543-2022·2022-02-16
Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0555-2022·2022-02-16
Cystex Tablet Recall Due to CGMP Manufacturing Deviations
ULTRAtab Laboratories is voluntarily recalling Cystex Tablets (Sodium Salicylate 162.5 mg, Methenamine 162 mg) in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The bulk product was distributed to 3 distributors.
Product
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0548-2022·2022-02-16
Acetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations
ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.
Product
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0549-2022·2022-02-16
Normed Fem Tablet Recalled Due to CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors who may have distributed finished product.
Product
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0542-2022·2022-02-16
Spearmint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.
Product
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0537-2022·2022-02-16
APAP 500 mg Acetaminophen Recalled Due to CGMP Deviations
ULTRAtab Laboratories is recalling APAP 500 mg SRC Coated tablets in bulk due to manufacturing process deviations. The company voluntarily initiated the Class II recall on January 26, 2022.
Product
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0534-2022·2022-02-16
Drug Recall: Coated APAP 500 mg Caplets for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 2 million Coated APAP 500 mg caplets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished product.
Product
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0525-2022·2022-02-16
Zee Cold Tabs Recalled for CGMP Manufacturing Deviations
ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0538-2022·2022-02-16
HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations
ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.
Product
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0554-2022·2022-02-16
DBI Magnums Caffeine Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 8.7 million tablets distributed to three distributors.
Product
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0530-2022·2022-02-16
Drug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations
ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Product
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0533-2022·2022-02-16
Drug Recall: Normed APAP 325 mg Acetaminophen Bulk Tablets
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.
Product
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0551-2022·2022-02-16
Back Relief II Drug Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.
Product
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0523-2022·2022-02-16
3-Component Cold Tabs Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.
Product
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0544-2022·2022-02-16
Ephedrine 25 Guaifenesin 200 Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin 200 bulk tablets due to manufacturing practice deviations. The voluntary recall affects about 7.3 million tablets distributed to three drug wholesalers.
Product
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0540-2022·2022-02-16
Cherry Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Cherry Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall.
Product
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0546-2022·2022-02-16
Drug Recall: Phenylephrine HCl 5mg Tablets Bulk Container
ULTRAtab Laboratories is recalling approximately 7.9 million Coated Phenylephrine HCl 5mg tablets in bulk containers due to manufacturing process deviations that may affect product quality and safety.
Product
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0535-2022·2022-02-16
Extra-Strength Unaspirin Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 6.2 million tablets distributed to three distributors.
Product
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0527-2022·2022-02-16
Dologen 325 Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were distributed to three distributors.
Product
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0532-2022·2022-02-16
Acetaminophen 325 mg Tablets Recalled Due to Manufacturing Deviations
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.
Product
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
Category
Drug
Distribution
0 states

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4351–4375 of 17964