Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,552
Critical: 1
Severe: 283
Most recent: 2026-09-02

Of the 1,552 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 283 (18%) 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 cgmp 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.

601–625 of 1552

ModerateFDA (Drugs)·D-0611-2022·2022-03-02
Target Severe Congestion Nasal Spray recalled for contaminated excipient
Perrigo Company is recalling Target Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%) because it was manufactured with a contaminated excipient that had been recalled from the supplier.
Product
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0613-2022·2022-03-02
Basic Care No Drip Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling 1,296 bottles of Basic Care No Drip Nasal Spray (oxymetazoline hydrochloride 0.05%) distributed nationwide due to contaminated excipient used during manufacturing.
Product
BASIC CARE NO DRIP NASAL — BASIC CARE NO DRIP NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0612-2022·2022-03-02
Perrigo TopCare Nasal Spray Recalled for Contaminated Excipient
TopCare Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) manufactured by Perrigo Company PLC is being recalled nationwide because the product was made with a contaminated excipient that was itself recalled by the supplier. Consumers should stop using affected batches.
Product
TOPCARE NASAL — TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0584-2022·2022-03-02
UP AND UP Acetaminophen Infant Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling UP AND UP Acetaminophen Infant Dye Free Grape Oral Suspension due to use of a contaminated excipient supplied by an outside vendor. The product was distributed nationwide.
Product
UP AND UP ACETAMINOPHEN — UP AND UP ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0607-2022·2022-03-02
CareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
Perrigo Company PLC is recalling 3,192 bottles of CareOne Severe Congestion Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) distributed nationwide because the products were manufactured with a contaminated excipient that was itself recalled from the supplier.
Product
CAREONE SEVERE CONGESTION NASAL — CAREONE SEVERE CONGESTION NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0598-2022·2022-03-02
Equate Infant Pain and Fever Acetaminophen Recall Due to Contaminated Excipient
Perrigo Company is recalling Equate infant's acetaminophen oral suspension due to manufacturing deviations involving a contaminated excipient from a supplier. The product was distributed nationwide.
Product
EQUATE PAIN AND FEVER — EQUATE PAIN AND FEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0624-2022·2022-03-02
Oxymetazoline Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling Maximum Strength No Drip Nasal Spray containing oxymetazoline HCl because it was manufactured with a contaminated excipient obtained from a recalled supplier.
Product
NASAL — NASAL (OXYMETAZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0581-2022·2022-03-02
Rugby Children's Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling Rugby Children's Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that had been recalled from the supplier.
Product
RUGBY CHILDRENS ACETAMINOPHEN — RUGBY CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0616-2022·2022-03-02
DG Health Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling DG Health Nasal (Oxymetazoline Hydrochloride) nasal spray because it was manufactured with a contaminated excipient obtained from a recalled supplier.
Product
DG HEALTH NASAL — DG HEALTH NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0625-2022·2022-03-02
TOPCARE NASAL Oxymetazoline HCl Recalled Due to Contaminated Excipient
Perrigo Company PLC is recalling TOPCARE NASAL (Oxymetazoline HCl 0.05%) nasal spray nationwide because products were manufactured with a contaminated excipient obtained from a supplier whose material was recalled.
Product
TOPCARE NASAL — TOPCARE NASAL (OXYMETAZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0623-2022·2022-03-02
Equaline Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling 1,560 bottles of Equaline Nasal No Drip Nasal Spray nationwide due to contaminated excipient used during manufacturing. The contaminated ingredient was sourced from a recalled excipient supplier.
Product
EQUALINE NASAL — EQUALINE NASAL (OXYMETAZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0583-2022·2022-03-02
Acetaminophen Child Strawberry Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) due to use of a contaminated excipient. The product was manufactured with a recalled ingredient from the excipient supplier.
Product
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0606-2022·2022-03-02
DG Health Nasal Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling DG Health Nasal Spray (Oxymetazoline HCl 0.05%) distributed nationwide because the product was manufactured with a contaminated excipient that was itself recalled from the supplier.
Product
DG HEALTH NASAL — DG HEALTH NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0597-2022·2022-03-02
Parents Choice Infant Acetaminophen Recalled for Contaminated Excipient
Perrigo Company is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) oral suspension nationwide due to CGMP deviations. The product was manufactured with a contaminated excipient that was recalled from the supplier.
Product
PARENTS CHOICE INFANTS PAIN AND FEVER — PARENTS CHOICE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0565-2022·2022-02-23
Alprazolam Tablets 0.5 mg Recalled Due to cGMP Deviations
ANI Pharmaceuticals is voluntarily recalling Alprazolam Tablets USP 0.5 mg in multiple package sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 205,662 bottles distributed across the United States.
Product
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0568-2022·2022-02-23
Pyrazinamide Tablets 500 mg Recalled Due to cGMP Deviations
ANI Pharmaceuticals, Inc. has recalled Pyrazinamide Tablets USP 500 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5,477 bottles distributed nationwide.
Product
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0567-2022·2022-02-23
Alprazolam Tablets 2.0 mg Recalled for cGMP Deviations
ANI Pharmaceuticals is recalling Alprazolam Tablets, USP 2.0 mg nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 70,788 bottles distributed throughout the United States.
Product
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0566-2022·2022-02-23
Alprazolam Tablets USP 1.0 mg Recalled for cGMP Deviations
ANI Pharmaceuticals has recalled Alprazolam Tablets USP 1.0 mg distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 173,499 bottles across multiple lot numbers.
Product
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0535-2022·2022-02-16
Extra-Strength Unaspirin Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 6.2 million tablets distributed to three distributors.
Product
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0523-2022·2022-02-16
3-Component Cold Tabs Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.
Product
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0552-2022·2022-02-16
Legatrin Acetaminophen and Diphenhydramine Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Legatrin bulk tablets due to manufacturing deviations that may affect product quality and safety. The company voluntarily initiated the recall after distributing approximately 14 million tablets to three distributors.
Product
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0545-2022·2022-02-16
Phenylephrine HCl 5 mg Tablet Recall Due to CGMP Deviations
ULTRAtab Laboratories is recalling Phenylephrine HCl 5 mg tablets in bulk containers due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 4.5 million tablets distributed to three distributors.
Product
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0544-2022·2022-02-16
Ephedrine 25 Guaifenesin 200 Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Ephedrine 25 Guaifenesin 200 bulk tablets due to manufacturing practice deviations. The voluntary recall affects about 7.3 million tablets distributed to three drug wholesalers.
Product
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0722-2022·2022-02-16
Electrolyte Tablets Recalled by ULTRAtab Laboratories Due to Manufacturing Deviations
ULTRAtab Laboratories has recalled approximately 26.6 million electrolyte tablets due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.
Product
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
Category
Food
Distribution
2 states
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