Hazard

Quality Control recalls

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

What the numbers show

Total: 354
Critical: 0
Severe: 128
Most recent: 2026-09-09

Of the 354 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 128 (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 354

LowFDA (Drugs)·D-0954-2016·2016-06-08
Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
Lupin Pharmaceuticals is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, because the active pharmaceutical ingredients used in manufacturing failed specifications.
Product
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0951-2016·2016-06-08
Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
Lupin Pharmaceuticals is recalling specific lots of Ceftriaxone for Injection USP because they were manufactured using active pharmaceutical ingredients that failed specifications.
Product
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1170-2016·2016-03-23
Zimmer Zimtron Hip Arthroplasty Heads Recalled for Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 226 sterile Zimtron hip arthroplasty heads due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.
Product
Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1158-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 1,394 sterile intramedullary fixation rods and reconstruction screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555…
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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1168-2016·2016-03-23
Zimmer Versys Heritage Femoral Stem Recall Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 360 units of Versys Heritage Femoral Stems due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.
Product
Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400…
Category
Medical Device
Distribution
Distributed nationwide
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 (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)…
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-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-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-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-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-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-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…
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-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-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-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