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 the agency’s own highest classification or reported deaths or serious injuries, 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

13526–13550 of 17799

ModerateFDA (Drugs)·D-1246-2015·2015-07-29
Wockhardt Recalls Extended Phenytoin Sodium Capsules Due to CGMP Deviations
Wockhardt USA is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules because the firm did not adequately investigate customer complaints.
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd.…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1248-2015·2015-07-29
Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA Inc. is recalling Azithromycin Tablets, USP, 250 mg because the firm did not adequately investigate customer complaints.
Product
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1244-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling specific lots of Lisinopril 2.5 mg tablets because the manufacturer did not adequately investigate customer complaints.
Product
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1267-2015·2015-07-29
Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures
Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg because the firm did not adequately investigate customer complaints.
Product
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1263-2015·2015-07-29
Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg because the firm did not adequately investigate customer complaints.
Product
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1250-2015·2015-07-29
Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 40 mg due to inadequate investigation of customer complaints.
Product
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1264-2015·2015-07-29
Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling 7,584 bottles of Azithromycin 600 mg tablets because the firm did not adequately investigate customer complaints.
Product
Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1252-2015·2015-07-29
Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.
Product
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1247-2015·2015-07-29
Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Zolpidem Tartrate 5 mg tablets because the firm did not adequately investigate customer complaints.
Product
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1243-2015·2015-07-29
Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Wockhardt USA LLC is recalling Amlodipine Besylate 2.5 mg tablets because the firm did not adequately investigate customer complaints.
Product
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1268-2015·2015-07-29
Wockhardt Recalls 15 mg Lansoprazole Capsules Due to CGMP Deviations
Wockhardt USA is recalling 16,276 bottles of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.
Product
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1272-2015·2015-07-29
Wockhardt Recalls Metoprolol Succinate Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.
Product
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1274-2015·2015-07-29
Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation
Wockhardt USA is recalling Zonisamide Capsules, 25 mg, because the firm did not adequately investigate customer complaints.
Product
Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1255-2015·2015-07-29
Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.
Product
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1259-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Lisinopril Tablets USP, 20 mg, due to inadequate investigation of customer complaints. The recall covers nationwide distribution.
Product
Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1253-2015·2015-07-29
Wockhardt Recalls Tamsulosin Hydrochloride Capsules Due to CGMP Deviations
Wockhardt USA Inc. is recalling Tamsulosin Hydrochloride Capsules because the firm did not adequately investigate customer complaints, a Current Good Manufacturing Practice (CGMP) deviation.
Product
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd.…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1266-2015·2015-07-29
Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations
Wockhardt USA is recalling 539 drums of Famotodine Tablets, 20 mg, because the firm did not adequately investigate customer complaints.
Product
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1257-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation
Wockhardt USA is recalling specific lots of Lisinopril 5 mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1245-2015·2015-07-29
Wockhardt Recalls Lamotrigine Extended-Release Tablets Due to CGMP Deviations
Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, because the firm did not adequately investigate customer complaints.
Product
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1262-2015·2015-07-29
Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Zolpidem Tartrate 10 mg tablets because the company did not adequately investigate customer complaints, a violation of current Good Manufacturing Practices.
Product
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1256-2015·2015-07-29
Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Wockhardt USA is recalling Amlodipine Besylate 10 mg tablets because the firm did not adequately investigate customer complaints.
Product
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1270-2015·2015-07-29
Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, 100 mg, because the firm did not adequately investigate customer complaints.
Product
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1249-2015·2015-07-29
Wockhardt Recalls Clarithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling 59,729 bottles of Clarithromycin 500 mg tablets because the firm did not adequately investigate customer complaints.
Product
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1261-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Lisinopril 40 mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1251-2015·2015-07-29
Wockhardt Recalls 15 mg Lansoprazole Capsules Due to Complaint Investigation Failures
Wockhardt USA is recalling 848 pouches of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.
Product
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC…
Category
Drug
Distribution
Distributed nationwide

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13526–13550 of 17799