Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,563
Critical: 1
Severe: 289
Most recent: 2026-09-09

Of the 1,563 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 289 (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.

626–650 of 1563

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-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-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-0527-2022·2022-02-16
Dologen 325 Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were distributed to three distributors.
Product
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0548-2022·2022-02-16
Acetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations
ULTRAtab Laboratories voluntarily recalled approximately 6.4 million APAP 325 mg tablets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished products.
Product
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0541-2022·2022-02-16
Trial Antacid Tablet bulk containers recalled for CGMP deviations
ULTRAtab Laboratories is recalling Trial Antacid Tablet bulk containers (Calcium Carbonate 420 mg) due to CGMP deviations. The product was distributed to three distributors who may have distributed finished product.
Product
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
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-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-0531-2022·2022-02-16
Acetaminophen 325 mg bulk tablets recalled for manufacturing deviations
ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.
Product
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
Category
Drug
Distribution
0 states
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-0540-2022·2022-02-16
Cherry Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Cherry Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall.
Product
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
Category
Drug
Distribution
0 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
ModerateFDA (Drugs)·D-0537-2022·2022-02-16
APAP 500 mg Acetaminophen Recalled Due to CGMP Deviations
ULTRAtab Laboratories is recalling APAP 500 mg SRC Coated tablets in bulk due to manufacturing process deviations. The company voluntarily initiated the Class II recall on January 26, 2022.
Product
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0529-2022·2022-02-16
APAP 325 mg/Phenylephrine HCl 5 mg Tablets Bulk Container Recall
ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.
Product
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
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 (Drugs)·D-0551-2022·2022-02-16
Back Relief II Drug Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.
Product
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0554-2022·2022-02-16
DBI Magnums Caffeine Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is voluntarily recalling DBI Magnums Tablet (Caffeine 200 mg) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 8.7 million tablets distributed to three distributors.
Product
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0538-2022·2022-02-16
HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations
ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.
Product
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0542-2022·2022-02-16
Spearmint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.
Product
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0549-2022·2022-02-16
Normed Fem Tablet Recalled Due to CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors who may have distributed finished product.
Product
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
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-0543-2022·2022-02-16
Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0525-2022·2022-02-16
Zee Cold Tabs Recalled for CGMP Manufacturing Deviations
ULTRAtab Laboratories is recalling Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg) in bulk form due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Category
Drug
Distribution
0 states