Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Other failed specifications
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present.
394 FDA drug recalls with this cause, newest first.
Every drug has a specification sheet: pH, viscosity, moisture, tablet hardness, colour, fill volume, disintegration time. A lot that misses any of them is out of specification, even when the active ingredient is present in the right amount. These recalls include discoloured tablets, crystals forming in a solution, capsules that split, and short-filled containers. They are rarely Class I, but they signal a process that has drifted.
- Total recalls
- 394
- Class I (high risk)
- 15
- Currently ongoing
- 83
- Most recent
- Jul 29, 2026
Most-cited firms for this cause
- Washington Homeopathic Products, Inc.39
- Hospira Inc.14
- Teva Pharmaceuticals USA12
- Sun Pharmaceutical Industries INC11
- Lupin Pharmaceuticals Inc.11
- Dr. Reddy's Laboratories, Inc.11
- ARG Laboratories, Inc.11
- Teva Pharmaceuticals USA, Inc.7
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class III · Low risk
Lidocaine Wound Gel
Failed PH Specifications
Class II · Moderate risk
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class III · Low risk
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
Failed Tablet/Capsule Specifications
Class III · Low risk
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class III · Low risk
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class II · Moderate risk
Diclofenac Sodium
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Class III · Low risk
Diclofenac Sodium Topical Gel
Failed PH Specifications
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class III · Low risk
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Tavaborole Topical solution 5%
Discoloration
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