Manufacturing (CGMP) Deviations recalls

2,434 recalls have been issued for manufacturing (cgmp) deviations, from 2012 to 9 Sep 2026. 121 of them came in the last 12 months. 5 were classified Class I.

Total recalls2,434since 2012

Last 12 months121reported

Class I50% of total

Ongoing455latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

2Oct '24 8 29 3Jan '25 2 6 51Apr 25 2 10Jul 4 2 5Oct 19 28 4Jan '26 2 23 3Apr 7 14 8Jul 2 6

Severity split

Class I 5 0%Class II 2,371 97%Class III 58 2%

Why manufacturing (cgmp) deviations is recalled

Manufacturing (CGMP) Deviations2,434100%

Companies

Cardinal Health1918%
Sunset Natural Products1737%
Health One Pharmaceuticals1466%
Mckesson Medical-Surgical Inc. Corporate Office1356%
Family Dollar Stores1165%
Accord Healthcare633%
Ultra Seal562%
Glenmark Pharmaceuticals Inc., U542%

Product types

Brands

By year

2026693%
20251576%
20241105%
202323610%
202252522%
202126411%
20201004%
20191265%
20181185%
201725811%

Ongoing manufacturing (cgmp) deviations recalls

455 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Myxredlin, Insulin Human in 9% Sodium Chloride Injection/mL) recalledMyxredlin	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Broadway Joe's Pain Cream, 3000 gm CBD recalled by Lexia	Lexia	Manufacturing (CGMP) Deviations	CO
9 Sep 2026Drug	CLASS II	Dexmedetomidine Hydrochloride recalled by Baxter Healthcare	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Broadway Joe's Pain Cream, (Histamine Dihydrochloride 025%) recalled	Lexia	Manufacturing (CGMP) Deviations	CO
9 Sep 2026Drug	CLASS II	Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
2 Sep 2026Drug	CLASS II	Zicam, Cold Remedy, Medicated Nasal Swabs recalled by Church & Dwight Co	Church & Dwight Co	Manufacturing (CGMP) Deviations	Nationwide

All manufacturing (cgmp) deviations recalls, newest first

2,434 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Myxredlin, Insulin Human in 9% Sodium Chloride Injection/mL) recalledMyxredlin	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Broadway Joe's Pain Cream, 3000 gm CBD recalled by Lexia	Lexia	Manufacturing (CGMP) Deviations	CO
9 Sep 2026Drug	CLASS II	Dexmedetomidine Hydrochloride recalled by Baxter Healthcare	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Broadway Joe's Pain Cream, (Histamine Dihydrochloride 025%) recalled	Lexia	Manufacturing (CGMP) Deviations	CO
9 Sep 2026Drug	CLASS II	Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
2 Sep 2026Drug	CLASS II	Zicam, Cold Remedy, Medicated Nasal Swabs recalled by Church & Dwight Co	Church & Dwight Co	Manufacturing (CGMP) Deviations	Nationwide
26 Aug 2026Drug	CLASS II	Carbamazepine Tablets, USP, 200mg recalled	SUN Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide
26 Aug 2026Drug	CLASS II	Carbamazepine Tablets, USP, 200mg recalledCarbamazepine	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2026Drug	CLASS II	Clomiphene Citrate USP Active Pharmaceutical Ingredient recalled	Shimoga Chemicals	Manufacturing (CGMP) Deviations	CA, FL
8 Jul 2026Drug	CLASS II	Synjardy XR Tablets (empagliflozin recalled by Boehringer Ingelheim	Boehringer Ingelheim Pharmaceuticals	Manufacturing (CGMP) Deviations	OH

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.