Granules Pharmaceuticals Initiates Class III Recall for Amphetamine Mixed Salts ER Capsules Over Impurity Failures
Granules Pharmaceuticals Inc. has initiated a Class III recall (D-0669-2025) for 3,384 bottles of its Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules. This voluntary, firm-initiated action stems from the product failing impurity and degradation specifications, impacting nationwide distribution from its Chantilly, VA facility. Procurement and regulatory teams must assess supply continuity and quality assurance protocols.
Granules Pharmaceuticals Initiates Class III Recall for Amphetamine Mixed Salts ER Capsules
Granules Pharmaceuticals Inc. has voluntarily initiated a Class III recall, designated D-0669-2025, for specific lots of its Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules. This critical regulatory action, initiated on August 28, 2025, directly impacts 3,384 bottles of the 5 mg strength, 100-capsule count product, identified by NDC 70010-029-01. The affected lot, GPC250158A, carries an expiration date of June 22, 2027. For procurement directors, this signifies an immediate disruption in the supply of this specific ADHD medication, necessitating a rapid assessment of current inventory levels and potential shortages within their distribution networks. Regulatory affairs heads must understand that a Class III classification indicates the product is unlikely to cause adverse health consequences, yet the underlying quality issue demands thorough investigation and corrective action from the manufacturer. This event underscores the continuous need for robust quality oversight in pharmaceutical manufacturing.
Product Quality Failure: Impurities Exceed Specifications
The primary reason for Granules Pharmaceuticals' recall is the product's failure to meet established impurity and degradation specifications. This means that during stability testing or routine quality checks, the levels of impurities or degradation products within the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate formulation exceeded acceptable limits. For regulatory affairs and quality assurance teams, this is a fundamental breach of Good Manufacturing Practices (GMP) and product quality standards. Such failures can compromise the drug's potency, safety, or stability over its shelf life, even if the immediate health risk is deemed low by a Class III classification. Business development executives should recognize that repeated quality issues, even for Class III recalls, can erode trust in a manufacturer's brand and lead to increased scrutiny from regulatory bodies like the FDA. Ensuring raw material quality, robust in-process controls, and comprehensive finished product testing are paramount to prevent such commercially damaging events.
Supply Chain Exposure: Nationwide Distribution Affected
The recalled Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules from Granules Pharmaceuticals Inc. were distributed nationwide across the USA. This broad distribution pattern means that wholesale distributors, pharmacies, and potentially healthcare providers across all states are exposed to this recall. Procurement directors must immediately initiate internal processes to identify and quarantine any affected lot GPC250158A inventory. The recall of 3,384 bottles, while not a massive volume in the broader pharmaceutical market, can still create localized supply gaps, particularly for a controlled substance used in ADHD treatment. Supply chain VPs need to assess the ripple effect on their downstream customers and ensure efficient communication and return logistics. This event highlights the critical importance of traceability within the pharmaceutical supply chain, enabling rapid identification and removal of non-conforming products to mitigate broader market disruption and maintain patient safety standards.
Granules Pharmaceuticals: Facility and Product Portfolio Context
Granules Pharmaceuticals Inc., the manufacturer of the recalled Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (ANDA217027), operates its manufacturing facility in Chantilly, VA 20151-1126, United States. This facility is responsible for producing human prescription drugs, including this specific amphetamine mixed salts product, which is available in various NDC codes such as 70010-029-01, 70010-030-01, and others. For business development executives, this recall, originating from a US-based facility, underscores that quality control challenges are not exclusive to offshore manufacturers. Regulatory affairs teams must closely monitor Granules Pharmaceuticals' response and corrective actions, as the FDA will expect a thorough investigation into the root cause of the impurity and degradation failures. The company's ability to swiftly and effectively address this issue will be crucial for maintaining its reputation and regulatory standing for its broader product portfolio, which includes other essential medications.