Hazard

Manufacturing Deviation recalls

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

What the numbers show

Total: 296
Critical: 0
Severe: 7
Most recent: 2026-09-09

Of the 296 manufacturing deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (2%) 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 manufacturing deviation 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.

276–296 of 296

ModerateFDA (Drugs)·D-1050-2020·2020-03-25
Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations
Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the product converting to Solifenacin Tartrate.
Product
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampu
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0790-2020·2020-01-22
Lupin Recalls Tri-Lo-Marzia Tablets Due to Blend Uniformity Deviations
Lupin Pharmaceuticals is recalling specific lots of Tri-Lo-Marzia oral contraceptives due to out-of-specification test results found during a retrospective review of blend uniformity data.
Product
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0349-2020·2019-11-20
Synthes Trial Spacers Recalled for Modified Manufacturing Process
Synthes (USA) Products LLC is recalling nine trial spacers with T-handles because they were modified outside of the approved manufacturing process.
Product
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Hand
Category
Medical Device
Distribution
1 state
ModerateFDA (Drugs)·D-1733-2019·2019-08-21
US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals Inc. is recalling 305 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests.
Product
MAXIMUM STRENGTH HYDROCORTISONE CREAM — MAXIMUM STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1729-2019·2019-08-21
US Pharmaceuticals Recalls Adult Glycerin Suppositories Due to Water Quality Issues
US Pharmaceuticals is recalling 196 cases of Adult Glycerin Suppositories because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
Product
Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1725-2019·2019-08-21
US Pharmaceuticals Recalls Intensive Healing Eczema Lotion for Water Quality Issues
US Pharmaceuticals is recalling Intensive Healing Eczema Lotion due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.
Product
INTENSIVE HEALING ECZEMA — INTENSIVE HEALING ECZEMA (HYDROCORTISONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0053-2019·2018-10-24
Thayers Saline Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing is recalling Thayers Saline Nasal Spray due to manufacturing conditions that could impact product quality.
Product
Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0033-2019·2018-10-24
CVS Health Baby Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling CVS Health Baby Nasal Spray/Drops due to manufacturing conditions that could impact product quality.
Product
CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0036-2019·2018-10-24
Saline Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Discount Drug Mart and Food Fair Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0038-2019·2018-10-24
Product Quest Recalls Saline Nasal Mist Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness Sterile Saline Nasal Mist because they were manufactured under conditions that could impact product quality.
Product
FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0088-2019·2018-10-17
GSK Recalls Prevacid 24HR Capsules Due to Manufacturing Deviations
GSK is voluntarily recalling Prevacid 24HR capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses have been reported.
Product
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0010-2019·2018-10-17
Pfizer Recalls Glipizide XL Tablets Due to Manufacturing Deviations
Pfizer is recalling 7,777 bottles of Glipizide XL 5 mg tablets because rejected product was used in manufacturing, violating CGMP standards.
Product
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0519-2017·2017-03-22
G&W Laboratories Recalls Clindamycin Phosphate Topical Solution Due to Expired Ingredient
G&W Laboratories is recalling specific lots of Clindamycin Phosphate Topical Solution because an expired active ingredient was used during manufacturing.
Product
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavi
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0165-2017·2016-12-07
Nationwide Laboratories Recalls Salsalate Tablets Due to Manufacturing Deviations
Nationwide Laboratories is recalling Salsalate Tablets, USP, 500 mg, because they were manufactured under practices that may result in assay or content uniformity failures.
Product
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0167-2017·2016-12-07
Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to Manufacturing Deviations
Nationwide Laboratories is recalling Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.
Product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0974-2016·2016-06-15
Aidarex Recalls Ceftriaxone for Injection Due to Manufacturing Deviations
Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection due to out-of-specification intermediates during manufacturing.
Product
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-66403-008·2013-11-13
Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations
Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-66403-012·2013-11-13
Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations
Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-66403-003·2013-11-13
Mylan Recalls Lamotrigine Tablets Due to Manufacturing Deviations
Mylan Pharmaceuticals is recalling 28,140 bottles of 200 mg Lamotrigine tablets because they were not manufactured according to Good Manufacturing Practices.
Product
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-077-2013·2012-12-12
Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations
Lloyd Inc. of Iowa is recalling specific lots of Levothroid tablets because they failed to meet in-process specification requirements.
Product
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-074-2013·2012-12-12
Lloyd Inc. Recalls Thyro-Tab Tablets Due to Manufacturing Deviations
Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab tablets because they failed to meet in-process specification requirements.
Product
Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Category
Drug
Distribution
Distributed nationwide