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.

551–575 of 1552

ModerateFDA (Drugs)·D-0686-2022·2022-03-30
Gentamicin Sulfate Cream USP 0.1% Recalled for cGMP Deviations
Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% distributed nationwide because the manufacturer is discontinuing its stability study program, which represents a deviation from FDA good manufacturing practices (cGMP).
Product
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0687-2022·2022-03-30
Gentamicin Sulfate Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Gentamicin Sulfate Ointment USP 0.1% due to cGMP deviations related to discontinuation of the firm's stability study program.
Product
Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0699-2022·2022-03-30
Triamcinolone Acetonide Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% nationwide because the manufacturer is discontinuing its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation.
Product
Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0688-2022·2022-03-30
Halobetasol Propionate Ointment Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Halobetasol Propionate Ointment 0.05% nationwide due to cGMP deviations. The manufacturer is discontinuing its stability study program.
Product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0703-2022·2022-03-30
Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.
Product
Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0670-2022·2022-03-30
Clobetasol Propionate Cream Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Cream USP 0.05% nationwide because the manufacturer is discontinuing its stability study program and cannot ensure compliance with current Good Manufacturing Practice standards.
Product
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0676-2022·2022-03-30
Desoximetasone Ointment USP 0.05% Recalled Due to cGMP Deviations
Teligent Pharma is recalling Desoximetasone Ointment USP 0.05% nationwide due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, affecting all products within expiry.
Product
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0679-2022·2022-03-30
Diclofenac Sodium Topical Solution recalled by Teligent Pharma
Teligent Pharma is recalling all unexpired batches of Diclofenac Sodium Topical Solution 1.5% due to current good manufacturing practice (cGMP) deviations related to discontinuation of the firm's stability study program.
Product
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0698-2022·2022-03-30
Triamcinolone Acetonide Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Triamcinolone Acetonide Lotion USP 0.025% due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0695-2022·2022-03-30
Nystatin and Triamcinolone Acetonide Ointment Recall Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Nystatin and Triamcinolone Acetonide Ointment (15g, 30g, and 60g tubes) nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.
Product
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0697-2022·2022-03-30
Triamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation
Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.
Product
Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0677-2022·2022-03-30
Desoximetasone Ointment USP 0.05% Recall Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Desoximetasone Ointment USP 0.05% (54,897 tubes) distributed nationwide because the manufacturer is discontinuing its stability study program, a violation of current good manufacturing practices.
Product
Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0692-2022·2022-03-30
Hydrocortisone Butyrate Lotion Recalled Due to cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% nationwide due to cGMP deviations. The firm discontinued its stability study program, prompting recall of all products within expiry.
Product
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0671-2022·2022-03-30
Clobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations
Teligent Pharma is recalling all unexpired Clobetasol Propionate Cream USP 0.05% nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the firm's stability study program.
Product
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0700-2022·2022-03-30
Clobetasol Propionate Cream USP Recalled for cGMP Deviations
Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP 0.05% in 60-gram tubes due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, affecting all products within expiry nationwide and in Puerto Rico.
Product
Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
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-0690-2022·2022-03-30
Hydrocortisone Butyrate Lotion recalled due to cGMP deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% (4 fl. oz. bottles) nationwide because the manufacturer discontinued its stability study program, which is a deviation from good manufacturing practice standards.
Product
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0673-2022·2022-03-30
Clobetasol Propionate Ointment USP 0.05% Nationwide Recall
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Ointment USP 0.05% nationwide because the manufacturer is discontinuing its stability study program, raising questions about product integrity.
Product
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0650-2022·2022-03-16
Alprazolam 1 mg recalled for potential cross-contamination at manufacturer
Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.
Product
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0651-2022·2022-03-16
Alprazolam 2 mg tablets recalled due to potential cross-contamination
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.
Product
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0639-2022·2022-03-09
Olanzapine 10 mg tablets recalled due to cGMP deviations
Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.
Product
OLANZAPINE — OLANZAPINE (OLANZAPINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0641-2022·2022-03-09
Over-The-Counter Drug Products Sold by Family Dollar Stores Recalled
Dollar Tree Distribution is recalling all over-the-counter drug products sold by Family Dollar retail stores in six states due to potential rodent exposure at a distribution center.
Product
All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
Category
Drug
Distribution
6 states
ModerateFDA (Drugs)·D-0632-2022·2022-03-09
Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations
Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
Product
AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
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-0595-2022·2022-03-02
Infants Pain and Fever Acetaminophen recalled for contaminated excipient
Perrigo Company is recalling Infants Pain and Fever Acetaminophen Infant Dye Free Grape Oral Suspension due to contaminated excipient used in manufacturing. The recall affects 1,296 bottles distributed nationwide.
Product
INFANTS PAIN AND FEVER — INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide