Hazard

Quality Control recalls

349 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 349
Critical: 0
Severe: 124
Most recent: 2026-09-02

Of the 349 quality control recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 124 (36%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality control recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

151–175 of 349

ModerateFDA (Devices)·Z-1107-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1108-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling specific lots of sterile 4.5 x 26 Cortical Screws due to insufficient sealer calibration data during packaging.
Product
Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0571-2016·2016-01-27
Morton Grove Recalls Lindane Lotion Due to Out-of-Specification Assay
Morton Grove Pharmaceuticals is recalling specific lots of Lindane Lotion because stability samples failed assay testing. Consumers should stop using the product and return it to their pharmacy.
Product
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0561-2016·2016-01-13
PD-Rx Pharmaceuticals Recalls Azithromycin 500 mg Tablets for cGMP Deviations
PD-Rx Pharmaceuticals is recalling Azithromycin 500 mg tablets because the original manufacturer did not adequately investigate customer complaints, resulting in cGMP deviations.
Product
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0520-2016·2015-12-16
Pfizer Recalls Norpace CR Capsules for Failed Dissolution Specification
Pfizer is recalling Norpace CR (disopyramide phosphate) capsules because they failed to meet dissolution specifications. The recall covers specific lots distributed nationwide.
Product
NORPACE CR — NORPACE CR (DISOPYRAMIDE PHOSPHATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0244-2016·2015-11-18
Cook Medical CXI Support Catheters Recalled Due to Product Mixing
Cook Inc. is recalling specific lots of CXI Support Catheters because the 2.6FR curved and 4.0FR straight catheters were mixed during processing.
Product
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Category
Medical Device
Distribution
10 states
ModerateFDA (Drugs)·D-0033-2016·2015-10-21
Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay
Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.
Product
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1346-2015·2015-08-26
Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations
Wockhardt USA is recalling 1,704 bottles of Lisinopril 5 mg tablets because an FDA inspection found inadequate investigations of past market complaints.
Product
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1347-2015·2015-08-26
Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations
Wockhardt USA LLC is recalling 3,378 bottles of Lisinopril 20 mg tablets because an FDA inspection found inadequate investigations of past market complaints.
Product
Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1282-2015·2015-08-05
Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
Mutual Pharmaceutical is recalling 20,892 bottles of Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.
Product
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1280-2015·2015-08-05
Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.
Product
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1281-2015·2015-08-05
Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.
Product
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Category
Drug
Distribution
0 states
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-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 0
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 W
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-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. Parsippan
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, Mu
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1260-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling specific lots of Lisinopril 30 mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), 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-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-1275-2015·2015-07-29
Wockhardt Recalls Captopril Tablets Due to CGMP Deviations
Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.
Product
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), 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-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-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. Parsippany
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2070-2015·2015-07-22
Exactech Recalls Four Ambassador Cervical Plate Systems
Exactech, Inc. is recalling four Ambassador Cervical Plate Systems that were shipped to a single consignee in Florida before final inspection was completed.
Product
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by hist
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1227-2015·2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to Complaint Investigation Failures
American Health Packaging is recalling 13,532 cartons of Lisinopril 10mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
Category
Drug
Distribution
Distributed nationwide