Hazard

Manufacturing Control recalls

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

What the numbers show

Total: 22
Critical: 0
Severe: 0
Most recent: 2025-07-02

Of the 22 manufacturing 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 0 (0%) 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 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.

1–22 of 22

ModerateFDA (Devices)·Z-2012-2025·2025-07-02
Caphosol Artificial Saliva sachets recalled for out-of-specification stability
Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.
Product
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0325-2025·2025-04-16
Glenmark Pharmaceuticals Recalls Pravastatin Sodium Tablets 80mg
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Pravastatin Sodium Tablets 80mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to affected lots distributed nationwide and was initiated voluntarily by the firm.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1146-2024·2024-02-28
Henry Schein Criterion Level 3 Earloop Masks Recalled for Non-Validated Equipment
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1147-2024·2024-02-28
Henry Schein Criterion Anti-Fog Earloop Masks Recalled for Equipment Validation Issue
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.
Product
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1481-2022·2022-09-14
Milk of Magnesia Recalled for Manufacturing Process Control Issues
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
Product
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0810-2022·2022-05-04
Compounded ST-2 pharmaceutical vials recalled for manufacturing process deviations
Olympia Compounding Pharmacy is recalling 2005 vials of ST-2, a compounded pharmaceutical, nationwide due to manufacturing practice deviations and failures to properly investigate environmental and personnel monitoring excursions.
Product
ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0705-2022·2022-03-30
Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations
Teligent Pharma, Inc. is recalling Lidocaine Ointment USP 5% nationwide because the manufacturer is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practice (cGMP). All products within their expiration dates are affected.
Product
Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.
Category
Drug
Distribution
Distributed nationwide
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-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-0553-2022·2022-02-16
Drug Recall: Coated Back Relief Tablet CGMP Deviations
ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.
Product
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0494-2022·2022-02-09
PAINAID PMF Premenstrual Formula Recalled for cGMP Deviations
Ultra Seal Corporation voluntarily recalled PAINAID PMF Premenstrual Formula packets nationwide due to cGMP (current Good Manufacturing Practice) deviations.
Product
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2022·2022-02-09
Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.
Product
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2022·2022-02-09
Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations
Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.
Product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0389-2022·2022-01-26
Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.
Product
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0085-2022·2021-11-10
Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
Dr. Reddy's Laboratories is recalling 696 bottles of Ezetimibe and Simvastatin Tablets (10 mg/40 mg) distributed nationwide due to failed excipient specifications and the presence of foreign tablets in bottles.
Product
EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0833-2021·2021-10-06
Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations
Johnson & Johnson Consumer is recalling Neutrogena Beach Defense water + sun protection sunscreen spray in two sizes (6.5 oz and 8.5 oz) nationwide due to current good manufacturing practice (cGMP) deviations.
Product
Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0660-2021·2021-07-21
Cipla Solifenacin Succinate Tablets Recalled for CGMP Deviations
Cipla USA is recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (Lot #GG90819, expiring 06/2021) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0087-2018·2017-11-29
FDA Recalls Extra Strength PreTAT Gel Due to Manufacturing Control Issues
Ridge Properties, LLC is recalling Extra Strength PreTAT by TAT BALM Gel because of inadequate manufacturing control processes. The product was distributed throughout the United States.
Product
Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0090-2018·2017-11-29
FDA Recalls Naturally HL Hemorrhoid Balm for Manufacturing Control Issues
Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Balm due to inadequate manufacturing control processes. The product was distributed throughout the United States.
Product
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0086-2018·2017-11-29
Ridge Properties Recalls Bed Sore Cream Due to Manufacturing Control Issues
Ridge Properties, LLC is recalling Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine due to inadequate manufacturing control processes.
Product
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0089-2018·2017-11-29
Ridge Properties Recalls Naturally HL Hemorrhoid Gel Due to Manufacturing Issues
Ridge Properties, LLC is recalling Naturally HL Liquid Hemorrhoid Relief Gel due to inadequate manufacturing control processes. The product was distributed throughout the United States.
Product
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Natu
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0088-2018·2017-11-29
FDA Recalls Naturally HL Hemorrhoid Spray for Manufacturing Control Issues
Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Spray due to inadequate manufacturing control processes. The product was distributed throughout the United States.
Product
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally H
Category
Drug
Distribution
0 states